Medication info
Epram Tablet 20 mg (Escitalopram Oxalate)

Epram Tablet 20 mg (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injection
Ingredient · strength
Escitalopram Oxalate›25.54mg / 1 tablet
Manufacturer / importer
HanIn Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle
Approval status
Active

MFDS item code 202002188 · Approved 2020.03.30 · Insurance code 657203630

Summary

Main use
Treatment of depressive disorders, anxiety disorders (including panic and social anxiety disorders), 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, without regard to meals. (1) Major depressive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day depending on the patient's response. 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 emerge. 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 that an initial dose of 5mg per day be administered for 1 week, followed by an increase to 10mg per day. The dose may be increased to a maximum of 20mg per day depending on the patient's response. Maximum effects appear 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 reevaluate 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, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day, depending on the patient's response. Social anxiety disorder is a disease with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment of patients who responded was studied for 6 months and should be considered for each patient individually to prevent relapse. The usefulness of long-term treatment should be reevaluated periodically. (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 reevaluate the usefulness of long-term treatment with this drug 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 depending on the patient's response. 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 disease, so this drug should be administered for a sufficient period to ensure symptom recovery. If this drug is administered long term, its usefulness and dosage should be reevaluated periodically for each 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 An initial dose of 5mg per day for the first 2 weeks is recommended. The dose may be increased to 10mg per day depending on the patient's response. 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 for the treatment of 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 to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or an intravenous methylene blue product, 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 an intravenous methylene blue product. The risk associated with administration of a methylene blue product by non-intravenous routes (oral tablets or local injection) or intravenous administration of this drug at a dose of 1mg/kg or less is unclear.

Ingredients

Manufacturer
HanIn Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of depressive disorders, anxiety disorders (including panic and social anxiety disorders), 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 several mental health disorders such as 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 drug is administered once daily, in the morning or evening, without regard to meals. (1) Major depressive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day depending on the patient's response. 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 emerge. 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 that an initial dose of 5mg per day be administered for 1 week, followed by an increase to 10mg per day. The dose may be increased to a maximum of 20mg per day depending on the patient's response. Maximum effects appear 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 reevaluate 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, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day, depending on the patient's response. Social anxiety disorder is a disease with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment of patients who responded was studied for 6 months and should be considered for each patient individually to prevent relapse. The usefulness of long-term treatment should be reevaluated periodically. (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 reevaluate the usefulness of long-term treatment with this drug 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 depending on the patient's response. 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 disease, so this drug should be administered for a sufficient period to ensure symptom recovery. If this drug is administered long term, its usefulness and dosage should be reevaluated periodically for each 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 An initial dose of 5mg per day for the first 2 weeks is recommended. The dose may be increased to 10mg per day depending on the patient's response. 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 for the treatment of 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 to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or an intravenous methylene blue product, 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 an intravenous methylene blue product. The risk associated with administration of a methylene blue product by non-intravenous routes (oral tablets or local injection) or intravenous administration of this drug at a dose of 1mg/kg or less is unclear.

Precautions

This medication is an antidepressant used to treat psychiatric disorders such as major depression. It is recommended not to use this medication in children and adolescents under 18 years old as its safety and efficacy have not been established. This medication may increase the risk of suicidal thoughts or behaviors; therefore, a cautious evaluation by a physician is necessary, especially when prescribing to young adults aged 18 to 24. If symptoms of depression worsen or if unusual behaviors such as suicidal thoughts, aggression, anxiety, or insomnia manifest during treatment, immediate consultation with a doctor is required. Family members or guardians should also closely monitor the patient's condition and notify healthcare professionals of any concerning signs. This medication should not be taken with certain drugs, especially MAO inhibitors, PimOzide, and drugs that prolong the QT interval, as serious side effects may occur. Caution should be exercised when using this medication in patients with glaucoma or a history of glaucoma as it may cause pupil dilation and increase intraocular pressure. During the first 1-2 weeks of treatment, side effects such as anxiety, insomnia, dizziness, nausea, and headaches may commonly occur, but most will alleviate over time. This medication may affect heart rhythm, so it is recommended that patients with heart disease or QT interval prolongation undergo an ECG before use. While taking antidepressants, avoid abrupt discontinuation of the medication; it should be gradually reduced under the guidance of a physician, as sudden discontinuation may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances. Women who are pregnant or breastfeeding should consult a physician before taking this medication as it may affect the newborn, and if breastfeeding, discontinuation or avoidance of the medication is recommended. Caution is needed when driving or operating machinery, and it is advisable not to consume alcohol while taking this medication. In case of overdose, serious symptoms like dizziness, convulsions, and heart arrhythmias may occur, so immediate medical attention is required. This medication should be kept out of reach of children and should not be transferred 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, irritability, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, paresthesia, tremors, taste disorders, sleep disturbances, syncope, serotonin syndrome, movement disorders, motor dysfunction, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, epistaxis, 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 disorders, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fractures, palpitations, hypertension, paralysis, extrapyramidal disorders, migraine, hallucinations, asthma, dyspnea, fractures, arthralgia, hypertension, dry mouth, tremor, abdominal discomfort, anxiety, insomnia, visual disturbances, frequency of urination, sedation, heartburn, restlessness, emotional instability, irritability, visual impairment, dizziness, sleep disturbances, confusion, sweating, diarrhea, palpitations, suicidal tendencies, suicidal impulses, suicidal behavior

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a sealed container. It is best to maintain storage temperatures between 1°C and 30°C at room temperature. This helps to preserve the medication's efficacy and safety over time.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 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.