Medication info
Lexa Tablets 10 mg (Escitalopram Oxalate)

Lexa Tablets 10 mg (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injection
Ingredient · strength
Escitalopram Oxalate›12.77mg / 1 tablet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
White, rectangular film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201906512 · Approved 2019.09.18 · Insurance code 657807280

Summary

Main use
Treatment of depressive disorders, anxiety disorders (e.g., panic disorder and social anxiety disorder), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
Safety has not been established for doses exceeding 20mg per day. This medication is administered once daily in the morning or evening, with or without food. 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 the dose is to be increased to 20mg, it should be increased at intervals of at least 1 week. In general, antidepressant effects take 2-4 weeks to develop. Even after symptoms have resolved, drug therapy for at least 6 months is necessary to ensure the treatment 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 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 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 chronic condition, and continued treatment for 12 weeks is recommended to ensure the treatment 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 periodically reassessed. (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 was conducted in patients who responded to 12 weeks of open-label treatment, with 20mg per day administered 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 treatment study was conducted in patients who responded to 16 weeks of open-label treatment, with 10mg or 20mg per day administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so treatment should be continued for a sufficient period to ensure recovery from symptoms. When this medication is used long term, its usefulness and dosage should be periodically reassessed 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. Depending on the patient's response, the dose may be increased to 10mg per day. 4) Discontinuation of treatment 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 At least 14 days should elapse between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication. Conversely, at least 14 days should elapse after discontinuing this medication before starting an MAO inhibitor to treat psychiatric disorders. 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 who require other interventional procedures, including hospitalization, or more urgent treatment for a psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this medication. If no alternative to linezolid or intravenous methylene blue is available 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 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 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 a nonintravenous route (oral tablets or local injection), or with intravenous administration of this medication at doses 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
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of depressive disorders, anxiety disorders (e.g., 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 effectively used for the treatment of major depressive disorder and panic disorder, both with or without agoraphobia. It is also used to treat social anxiety disorder, commonly known as social phobia, generalized anxiety disorder, and obsessive-compulsive disorder. It helps alleviate and treat these mental health issues, contributing to improvements in patients' symptoms and quality of life. Hence, this medication is used for treating depression and anxiety-related disorders.

How it is given

Adult administration

Safety has not been established for doses exceeding 20mg per day. This medication is administered once daily in the morning or evening, with or without food. 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 the dose is to be increased to 20mg, it should be increased at intervals of at least 1 week. In general, antidepressant effects take 2-4 weeks to develop. Even after symptoms have resolved, drug therapy for at least 6 months is necessary to ensure the treatment 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 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 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 chronic condition, and continued treatment for 12 weeks is recommended to ensure the treatment 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 periodically reassessed. (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 was conducted in patients who responded to 12 weeks of open-label treatment, with 20mg per day administered 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 treatment study was conducted in patients who responded to 16 weeks of open-label treatment, with 10mg or 20mg per day administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so treatment should be continued for a sufficient period to ensure recovery from symptoms. When this medication is used long term, its usefulness and dosage should be periodically reassessed 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. Depending on the patient's response, the dose may be increased to 10mg per day. 4) Discontinuation of treatment 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 At least 14 days should elapse between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication. Conversely, at least 14 days should elapse after discontinuing this medication before starting an MAO inhibitor to treat psychiatric disorders. 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 who require other interventional procedures, including hospitalization, or more urgent treatment for a psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this medication. If no alternative to linezolid or intravenous methylene blue is available 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 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 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 a nonintravenous route (oral tablets or local injection), or with intravenous administration of this medication at doses 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 is an antidepressant used to treat psychiatric disorders such as major depression. It may increase the risk of suicidal thoughts or behaviors, particularly in children, adolescents, and young adults aged 18 to 24. Therefore, careful evaluation by a doctor is necessary when prescribing to patients in this age group. During the treatment with this medication, family members or caregivers should closely observe for any worsening of depressive symptoms, suicidal thoughts, aggression, anger, or any abnormal behavioral changes, and consult a doctor immediately if such symptoms occur. This medication can be risky if taken with certain other drugs, so it should not be taken with MAO inhibitors, pimozide, or any medications that may prolong the QT interval. Patients with closed-angle glaucoma or a history of glaucoma need to be cautious as the drug’s mydriatic effect may increase intraocular pressure. Initial side effects such as anxiety, agitation, insomnia, dizziness, nausea, headache may occur but usually subside with time. This drug may affect blood coagulation, so patients taking anticoagulants should be closely monitored for bleeding risks. Do not abruptly stop taking this medication; it should be gradually reduced according to a doctor's guidance to prevent withdrawal symptoms. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, particularly in late pregnancy as it may affect the newborn. For the elderly, it is safer to start at a reduced dose, and caution is required for patients with heart disease due to risks of cardiac arrhythmias. This medication does not significantly impair driving or machinery operation but caution may still be necessary on an individual basis. In case of overdose, symptoms such as dizziness, nausea, and heart rhythm abnormalities may occur, requiring immediate medical attention. This medication is not recommended for children and adolescents as its safety and efficacy have not been established.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate secretion of antidiuretic hormone, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, loss of appetite, anxiety, agitation, abnormal dreams, decreased libido, sexual dysfunction, bruxism, restlessness, irritability, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, dysesthesia, tremor, taste disorder, sleep disorder, syncope, serotonin syndrome, movement disorders, motor dysfunction, convulsions, 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, ejaculation disorder, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory abnormalities, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, frequent urination, tremors, dry mouth, sedation, heartburn, anxiety, visual hallucinations, emotional instability, hypersensitivity, visual impairment

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

Storage

This medication should be stored in a tightly closed container as it may be sensitive to air and moisture. It is also important to store it at room temperature between 1°C to 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

White, rectangular film-coated tablets

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.