Medication info
Escitalopram Oxalate 15 mg Tablet

Escitalopram Oxalate 15 mg Tablet

Prescription medicationTabletIntravenous injection
Ingredient · strength
Escitalopram Oxalate›19.155mg / 1 tablet
Manufacturer / importer
Hyundai Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202402283 · Approved 2024.09.23 · Insurance code 642005310

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 per day has not been established. This drug 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. 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 required for antidepressant effects to become apparent. Even after symptoms have resolved, medication treatment for at least 6 months is required to ensure the therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended that an initial dose of 5mg per day be administered for 1 week, followed by an 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 drug 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, 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 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 used only when social anxiety disorder significantly interferes with occupational and social activities. A comparison of drug treatment with cognitive behavioral therapy has not been evaluated. Drug treatment is one part of an overall treatment strategy. (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, administering 20mg per day for at least 6 months. The physician should regularly reassess the usefulness of long-term treatment with this drug 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, administering 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, and treatment should be continued for a sufficient period to ensure recovery from symptoms. If this drug is used long term, the usefulness and dosage should be regularly reassessed for each individual 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 drug, 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 a psychiatric disorder and starting treatment with this drug, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue preparations should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue preparations to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue preparations is available and the benefits of treatment with linezolid or intravenous methylene blue preparations are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug may be discontinued immediately and linezolid or intravenous methylene blue preparations administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks after starting linezolid or intravenous methylene blue preparations, or until 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue preparations. The risk associated with methylene blue preparations administered by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this drug 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
Hyundai Pharmaceutical 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 medicine is used to treat various mental health issues such as major depressive disorder, panic disorder (including cases with or without 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 drug 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. 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 required for antidepressant effects to become apparent. Even after symptoms have resolved, medication treatment for at least 6 months is required to ensure the therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended that an initial dose of 5mg per day be administered for 1 week, followed by an 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 drug 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, 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 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 used only when social anxiety disorder significantly interferes with occupational and social activities. A comparison of drug treatment with cognitive behavioral therapy has not been evaluated. Drug treatment is one part of an overall treatment strategy. (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, administering 20mg per day for at least 6 months. The physician should regularly reassess the usefulness of long-term treatment with this drug 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, administering 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, and treatment should be continued for a sufficient period to ensure recovery from symptoms. If this drug is used long term, the usefulness and dosage should be regularly reassessed for each individual 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 drug, 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 a psychiatric disorder and starting treatment with this drug, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue preparations should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue preparations to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue preparations is available and the benefits of treatment with linezolid or intravenous methylene blue preparations are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug may be discontinued immediately and linezolid or intravenous methylene blue preparations administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks after starting linezolid or intravenous methylene blue preparations, or until 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue preparations. The risk associated with methylene blue preparations administered by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this drug 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 may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depression or other psychiatric disorders, so it should be used with extreme caution. Especially, its use is not approved for children and adolescents under 18 years old, hence it is advisable not to administer it to them. This medication should not be given to patients with allergies to the active ingredient or other components, or to those taking MAO inhibitors, pimozide, or medications that prolong the QT interval. Patients with angle-closure glaucoma or a history of glaucoma should use this drug cautiously as it may dilate the pupil and increase intraocular pressure. Symptoms such as anxiety, agitation, and insomnia may appear in the first 1-2 weeks of administration, but they usually decrease over time. This medication can cause various side effects including dizziness, nausea, drowsiness, headache, and decreased libido, so consult a healthcare professional if any unusual symptoms arise. If there are signs of abnormal behavior changes such as suicidal impulses, aggression, or hallucinations, inform a healthcare provider immediately. This medication may cause withdrawal symptoms such as dizziness, anxiety, and sleep disturbances if suddenly discontinued, so the dose should be gradually reduced under medical supervision. Patients with heart disease or QT interval prolongation should undergo an electrocardiogram before taking this medication and should have their heart condition monitored regularly during treatment. Women who are pregnant or breastfeeding should consult their doctor before using this medication, as it may affect the fetus or newborn, and it is recommended to discontinue breastfeeding if using this drug. Caution should be exercised when taking this medication in combination with other serotonin-active drugs, as it can cause a serious side effect known as serotonin syndrome. Care should be taken when driving or operating machinery, and it is advisable to avoid consuming alcohol while taking this drug. Store in a safe place out of the reach of children and do not transfer to another container.

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, nervousness, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, altered perception, tremors, dysgeusia, sleep disorders, syncope, serotonin syndrome, dyskinesia, movement disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval on ECG, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, nosebleed, nausea, diarrhea, constipation, vomiting, polydipsia, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, alopecia, rash, itching, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculation disorder, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, hallucination, asthma, dyspnea, fracture, arthralgia, hypertension, xerostomia, tremor, weight gain, abdominal discomfort, anxiety, insomnia, visual hallucinations, frequent urination, sedation, heartburn, xerostomia, decreased libido, decreased appetite, sweating, frequent urination, sexual dysfunction, tremor, weight gain, nausea, headache, dizziness, drowsiness, gastrointestinal disorders, diarrhea, palpitations, emotional instability, irritability, visual impairment

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 special container that does not allow light in. Additionally, it should be kept at room temperature between 1°C and 30°C 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.