Medication info
Escitalopram Oxalate 5 mg Tablet

Escitalopram Oxalate 5 mg Tablet

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

MFDS item code 202000518 · Approved 2020.01.31 · Insurance code 628901550

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (including panic disorder and social anxiety disorder), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
The safety of doses exceeding 20mg per day has not been established. This medicine is administered once daily, in the morning or evening, regardless of meals. 1) Adults (1) Major depressive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response. If increasing the dose of this medicine 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, drug treatment for at least 6 months is required to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer 5mg once daily as the initial dose for 1 week, then increase to 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response. The maximum effect appears 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. 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, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day, according to the patient's response. 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 respond has been studied for 6 months, and should be considered for each individual patient 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 treatment should be given only when social anxiety disorder significantly interferes with occupational and social activities. Drug treatment has not been compared with cognitive behavioral therapy. Drug treatment is one part of an overall treatment strategy. (4) Generalized anxiety disorder: The initial dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response, after administration for at least 1 week. A long-term administration 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 medicine for each patient. (5) Obsessive-compulsive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response. A long-term administration 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 this medicine should be administered for a sufficient period to ensure symptom recovery. When this medicine is administered long term, its usefulness and dosage should be regularly reassessed for each individual patient. 2) Patients with renal impairment No dose adjustment is required for 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 an initial dose of 5mg per day for the first 2 weeks. The dose may be increased to 10mg per day according to the patient's response. 4) Discontinuation of treatment When discontinuing this medicine, 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 medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue preparations should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, administration should be considered. It may be necessary to urgently administer linezolid or an intravenous methylene blue preparation to a patient already receiving this medicine. 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 medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient should be monitored 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 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 medicine 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 these uses.

Ingredients

Manufacturer
Eden Pharma 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 medication is used to treat major depressive disorder, panic disorder (including or excluding agoraphobia), social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder.

How it is given

Adult administration

The safety of doses exceeding 20mg per day has not been established. This medicine is administered once daily, in the morning or evening, regardless of meals. 1) Adults (1) Major depressive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response. If increasing the dose of this medicine 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, drug treatment for at least 6 months is required to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer 5mg once daily as the initial dose for 1 week, then increase to 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response. The maximum effect appears 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. 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, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day, according to the patient's response. 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 respond has been studied for 6 months, and should be considered for each individual patient 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 treatment should be given only when social anxiety disorder significantly interferes with occupational and social activities. Drug treatment has not been compared with cognitive behavioral therapy. Drug treatment is one part of an overall treatment strategy. (4) Generalized anxiety disorder: The initial dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response, after administration for at least 1 week. A long-term administration 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 medicine for each patient. (5) Obsessive-compulsive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response. A long-term administration 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 this medicine should be administered for a sufficient period to ensure symptom recovery. When this medicine is administered long term, its usefulness and dosage should be regularly reassessed for each individual patient. 2) Patients with renal impairment No dose adjustment is required for 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 an initial dose of 5mg per day for the first 2 weeks. The dose may be increased to 10mg per day according to the patient's response. 4) Discontinuation of treatment When discontinuing this medicine, 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 medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue preparations should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, administration should be considered. It may be necessary to urgently administer linezolid or an intravenous methylene blue preparation to a patient already receiving this medicine. 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 medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient should be monitored 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 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 medicine 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 these uses.

Precautions

This drug is an antidepressant used for the treatment of psychiatric disorders such as major depression. Caution should be exercised when using this medication in children, adolescents, and young adults (ages 18-24) as the risk of suicide thoughts or behavior may increase. It should not be administered if there is an allergy to this drug or if it is being taken with certain medications. Caution is needed in patients with glaucoma or a history of closed-angle glaucoma. Adverse reactions may frequently occur within the first 1-2 weeks of taking this medication, but they often decrease over time. Various side effects such as anxiety, insomnia, dizziness, nausea, weight changes, and sexual dysfunction have been reported. Close observation for worsening depression symptoms or signs of suicide risk should be conducted, particularly during the initial treatment with antidepressants, and family members or caregivers should be vigilant in monitoring the patient. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it should be gradually tapered as directed by a healthcare professional. Care should be taken in patients with heart diseases or those at risk for QT interval prolongation, and patients must inform their healthcare provider of all medications they are taking due to potential drug interactions. Women who are pregnant or breastfeeding should consult a physician before taking this medication, as it may have effects on the newborn. Older adults should start with a reduced dose for safety. Caution is advised when driving or operating machinery. Serious symptoms may occur in case of overdose, so the prescribed dosage and administration should be strictly followed. This medication is not recommended for children and adolescents.

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, irritability, 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 disturbances, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation on electrocardiogram, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, nosebleed, nausea, diarrhea, constipation, vomiting, thirst, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, hives, 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, indigestion, enteritis, sensory disturbances, cough, asthma, shortness of breath, fracture, palpitations, hypertension, paralysis, extrapyramidal disorders, migraine, chest pain, frequent urination, tremor, emotional instability, hypersensitivity, visual hallucination

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

Storage

This medication should be stored in a container that protects it from light, as it is light-sensitive. It should also be stored at a temperature between 1°C and 30°C to maintain 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.