Medication info
Lexamel 10mg (Escitalopram Oxalate)

Lexamel 10mg (Escitalopram Oxalate)

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

MFDS item code 201603696 · Approved 2016.06.21 · Insurance code 669501970

Summary

Main use
Treatment of major depressive disorder and anxiety disorders (panic disorder, social anxiety disorder, and generalized 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 of this medication is to be increased to 20mg, the increase should be made at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to appear. Even after symptoms have resolved, drug treatment for at least 6 months is required to ensure the therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer 5mg per day for 1 week as the initial dose, 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. (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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure the therapeutic effect. Long-term treatment in patients who responded was studied for 6 months, and should be considered on an individual patient basis to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. (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 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 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 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, so treatment should continue for a sufficient period to ensure symptom recovery. If this medication is administered long term, the usefulness and dose should be regularly reassessed for each patient. 2) Patients with renal impairment No dose adjustment is required 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 It is recommended to administer 5mg per day as the initial dose for the first 2 weeks. 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 reduced gradually 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 must be allowed. Conversely, if starting an MAO inhibitor for the treatment of psychiatric disorders, at least 14 days must elapse 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 interventions, including hospitalization, or more urgent treatment of a psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. 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 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 a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medication at 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
CTC Bio, Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder and anxiety disorders (panic disorder, social anxiety disorder, and generalized 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.

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 of this medication is to be increased to 20mg, the increase should be made at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to appear. Even after symptoms have resolved, drug treatment for at least 6 months is required to ensure the therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer 5mg per day for 1 week as the initial dose, 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. (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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure the therapeutic effect. Long-term treatment in patients who responded was studied for 6 months, and should be considered on an individual patient basis to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. (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 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 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 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, so treatment should continue for a sufficient period to ensure symptom recovery. If this medication is administered long term, the usefulness and dose should be regularly reassessed for each patient. 2) Patients with renal impairment No dose adjustment is required 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 It is recommended to administer 5mg per day as the initial dose for the first 2 weeks. 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 reduced gradually 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 must be allowed. Conversely, if starting an MAO inhibitor for the treatment of psychiatric disorders, at least 14 days must elapse 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 interventions, including hospitalization, or more urgent treatment of a psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. 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 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 a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medication at 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 primarily used to relieve symptoms associated with depression. This drug may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults aged 18 to 24, so when administered to patients in this age group, doctors should carefully assess the risks and benefits. This drug should not be used in conjunction with certain medications, especially MAO inhibitors, pimozide, and drugs known to prolong the QT interval, as serious side effects may occur. Patients with glaucoma or a history of glaucoma should exercise caution as this drug may dilate the pupils and increase intraocular pressure. During the initial 1-2 weeks of administration, symptoms such as anxiety, insomnia, dizziness, and nausea may frequently occur, but these symptoms tend to gradually decrease over time. This drug can affect heart rhythm, so patients with a prolonged QT interval or heart disease may require an ECG before administration. Abnormal behavioral changes such as suicidal thoughts, aggression, and anxiety may occur during antidepressant treatment, hence patients and caregivers should monitor closely. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; it should be reduced gradually under medical supervision. Women who are pregnant or breastfeeding should consult their physician before using this medication as it may affect the newborn. This drug requires dosage adjustments for patients with compromised liver function or the elderly, and it should be used cautiously with other medications due to the potential for drug interactions. Care should be taken when driving or operating machinery due to potential effects on mental functions caused by this medication. In case of overdose, symptoms such as dizziness, tremors, nausea, arrhythmia may occur, and immediate medical assistance should be sought. This medication should be stored out of reach of children, and it is safer not to transfer it to other containers.

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, neuroticism, panic attack, confusion, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, sensory disturbances, tremors, taste disorders, sleep disorders, fainting, serotonin syndrome, movement disorders, dyskinesia, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation on ECG, polymorphic ventricular tachycardia, 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 disturbances, cough, asthma, shortness of breath, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, frequent urination, sedation, tremor, nausea, anxiety, insomnia, visual hallucinations, retrograde anxiety, epileptic seizure, mania, changes in blood sugar control, suicidal impulses, suicidal behavior, hostility, aggression, impulsivity, akathisia, hypomania, anxiety, restlessness, panic disorder, insomnia, excitement, antagonism, withdrawal symptoms (dizziness, sleep disorders, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual impairment), hypokalemia, hypomagnesemia

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 blocks light. Additionally, it is important to keep the medication at room temperature, between 1 to 30 degrees Celsius, to maintain its efficacy.

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.