Medication info

Jeongheon Escitalopram Tablet 10 mg (Escitalopram Oxalate)

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

MFDS item code 201902904 · Approved 2019.05.07

This product's status changed to Expired on 2024.05.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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
Safety has not been established for doses exceeding 20mg per day. This drug is administered once daily in the morning or evening, regardless of meals. 1) Adults (1) Major depressive disorder: The usual dosage is 10mg once daily. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day. If increasing the dosage of this drug 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 develop. 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: The recommended initial dosage is 5mg per day for 1 week, followed by an increase to 10mg per day. Depending on the patient's response, the dosage 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 dosage is 10mg once daily. Generally, 2-4 weeks are needed for symptoms to improve. Thereafter, depending on the patient's response, the dosage 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 responding patients 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 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. 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 dosage is 10mg once daily. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day after at least 1 week of treatment. A long-term administration trial 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 drug for each patient. (5) Obsessive-compulsive disorder: The usual dosage is 10mg once daily. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day. A long-term administration trial 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, and treatment should be continued for a sufficient period to ensure recovery from symptoms. When this drug is administered long term, its usefulness and dosage should be reassessed regularly for each patient. 2) Patients with renal impairment No dosage adjustment is necessary in patients with mild or moderate renal impairment. Caution should be exercised in patients with severe renal impairment (CLCR < 30 mL/min). 3) Patients with hepatic impairment An initial dosage of 5mg per day for the first 2 weeks is recommended. Depending on the patient's response, the dosage may be increased to 10mg per day. 4) Discontinuation of treatment When discontinuing this drug, the dosage 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 drug, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, 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 who require more urgent treatment for a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or an intravenous methylene blue preparation to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this drug 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 drug 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 drug 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
Jeongheon 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 medication is used for the treatment of 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

Safety has not been established for doses exceeding 20mg per day. This drug is administered once daily in the morning or evening, regardless of meals. 1) Adults (1) Major depressive disorder: The usual dosage is 10mg once daily. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day. If increasing the dosage of this drug 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 develop. 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: The recommended initial dosage is 5mg per day for 1 week, followed by an increase to 10mg per day. Depending on the patient's response, the dosage 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 dosage is 10mg once daily. Generally, 2-4 weeks are needed for symptoms to improve. Thereafter, depending on the patient's response, the dosage 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 responding patients 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 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. 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 dosage is 10mg once daily. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day after at least 1 week of treatment. A long-term administration trial 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 drug for each patient. (5) Obsessive-compulsive disorder: The usual dosage is 10mg once daily. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day. A long-term administration trial 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, and treatment should be continued for a sufficient period to ensure recovery from symptoms. When this drug is administered long term, its usefulness and dosage should be reassessed regularly for each patient. 2) Patients with renal impairment No dosage adjustment is necessary in patients with mild or moderate renal impairment. Caution should be exercised in patients with severe renal impairment (CLCR < 30 mL/min). 3) Patients with hepatic impairment An initial dosage of 5mg per day for the first 2 weeks is recommended. Depending on the patient's response, the dosage may be increased to 10mg per day. 4) Discontinuation of treatment When discontinuing this drug, the dosage 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 drug, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, 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 who require more urgent treatment for a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or an intravenous methylene blue preparation to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this drug 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 drug 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 drug 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 for the treatment of psychiatric disorders such as major depression. In children, adolescents, and young adults, the risk of suicidal thoughts or actions may increase, so a doctor's careful assessment is necessary before administration. If there is an allergy to the active ingredients or other components of this drug, or if taken in conjunction with specific drugs, it may pose a risk, and consultation with a doctor is essential. Particularly, it should not be administered to patients taking MAO inhibitors, pimozide, or drugs that prolong the QT interval. In patients with glaucoma or a history of glaucoma, caution is needed as this drug may dilate the pupil and increase intraocular pressure. Adverse reactions may occur in the first 1-2 weeks of administration, including anxiety, insomnia, nausea, headache, weight changes, etc. This medication may induce changes in mental state, such as suicidal thoughts or behavior, and aggression, so patients and families should observe carefully. Patients with epilepsy may have an increased risk of seizures, so caution is needed during administration. Diabetic patients may be affected in blood sugar control, so thorough blood sugar management is required. This drug may produce withdrawal symptoms such as dizziness, anxiety, sleep disturbances, etc., if suddenly discontinued; therefore, the dosage should be gradually reduced according to the doctor's instructions. Patients with heart disease or an increased risk of QT interval prolongation require an ECG examination before administration, and immediate consultation with healthcare personnel is necessary if abnormal symptoms appear. In cases of pregnancy or breastfeeding, a careful decision regarding the administration of this drug is essential as it may affect the newborn. Caution should be exercised when driving or operating machinery, based on symptoms. In case of overdose, symptoms may appear in the central nervous system, gastrointestinal tract, and cardiovascular system, so immediate emergency treatment should be sought, and there is no specific antidote. This medication should be kept out of the reach of children, and it is safer not to transfer it to another container.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, irritability, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual abnormalities, tremors, taste disorders, sleep disorders, syncope, serotonin syndrome, movement disorders, motor disabilities, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval on electrocardiogram, polymorphic ventricular tachycardia, ventricular arrhythmias, orthostatic hypotension, sinusitis, yawning, nosebleeds, nausea, diarrhea, constipation, vomiting, polydipsia, 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 bleeding, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory abnormalities, cough, asthma, shortness of breath, fractures, palpitations, hypertension, insomnia, aggressive reactions, anorexia, visual hallucinations, sedation, frequent urination, tremors, paralysis, extrapyramidal disorder, migraine, chest pain, dry mouth, nausea, tremors, confusion, sweating, diarrhea, 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 light-protected, tightly sealed container, and the storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. Proper storage maintains the efficacy of the medication and ensures safe usage.

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.