Medication info
Epram Tablet 15 mg (Escitalopram Oxalate)

Epram Tablet 15 mg (Escitalopram Oxalate)

Prescription medicationTablet
Ingredient · strength
Escitalopram Oxalate›19.16mg / 1 tablet
Manufacturer / importer
Hwanin Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201500296 · Approved 2015.01.20 · Insurance code 657203220

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (e.g., panic disorder and social anxiety disorder), and obsessive-compulsive disorder
Who uses it
Adults
Adult dosage
Safety has not been established for doses exceeding 20mg per day. This medicine should be administered once daily, in the morning or evening, regardless of 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 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 antidepressant effects to become apparent. Even after symptoms have resolved, drug treatment for at least 6 months is required to ensure the treatment effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer an initial dose of 5mg per day for 1 week, then increase to 10mg per day. The dose may be increased to a maximum of 20mg per day depending on 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 depending on the patient's response. Social anxiety disorder is a condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure the treatment 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. (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 administration 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 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 depending on the patient's response. A long-term administration 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 condition, so this medicine should be administered for a sufficient period to ensure recovery from symptoms. If this medicine is administered long term, the benefit and dose for each patient should be reassessed regularly. 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. The dose may be increased to 10mg per day depending on 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 should 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 this medicine because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or 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 an intravenous methylene blue preparation is available, and the benefits of treatment with linezolid or an intravenous methylene blue preparation are judged to outweigh the risk of serotonin syndrome in a particular patient, this medicine may be discontinued immediately and linezolid or an intravenous methylene blue preparation may be administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or an intravenous methylene blue preparation, or until 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 an intravenous methylene blue preparation. 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
Hwanin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (e.g., 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 panic disorder, social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder, regardless of whether they are accompanied by major depressive disorder or agoraphobia.

Dosage and Administration

Adult dosage

Safety has not been established for doses exceeding 20mg per day. This medicine should be administered once daily, in the morning or evening, regardless of 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 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 antidepressant effects to become apparent. Even after symptoms have resolved, drug treatment for at least 6 months is required to ensure the treatment effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer an initial dose of 5mg per day for 1 week, then increase to 10mg per day. The dose may be increased to a maximum of 20mg per day depending on 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 depending on the patient's response. Social anxiety disorder is a condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure the treatment 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. (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 administration 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 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 depending on the patient's response. A long-term administration 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 condition, so this medicine should be administered for a sufficient period to ensure recovery from symptoms. If this medicine is administered long term, the benefit and dose for each patient should be reassessed regularly. 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. The dose may be increased to 10mg per day depending on 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 should 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 this medicine because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or 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 an intravenous methylene blue preparation is available, and the benefits of treatment with linezolid or an intravenous methylene blue preparation are judged to outweigh the risk of serotonin syndrome in a particular patient, this medicine may be discontinued immediately and linezolid or an intravenous methylene blue preparation may be administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or an intravenous methylene blue preparation, or until 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 an intravenous methylene blue preparation. 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 medication is an antidepressant used for the treatment of major depression. This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so it should be prescribed with caution for patients in this age group. Additionally, all patients taking this medication should be monitored closely for abnormal behavior changes such as suicidal impulses, aggression, anxiety, etc., especially at the beginning of treatment, and family members or caregivers should also closely observe the patient's condition. This medication should not be taken with certain drugs. For example, it can be dangerous to take it in combination with MAO inhibitors, pimozide, or drugs that prolong the QT interval. Patients with closed-angle glaucoma or a history of glaucoma should exercise caution due to the risk of increased intraocular pressure from the dilation effect of this medication. During the first 1-2 weeks of treatment, side effects such as insomnia, anxiety, dizziness, nausea, and headaches may commonly occur, usually alleviating over time. This medication can affect blood glucose control, so diabetic patients should monitor their blood sugar levels closely. Serious side effects known as serotonin syndrome may occur while taking this medication; if symptoms such as fever, tremors, confusion, and severe diarrhea appear, consult a doctor immediately. Sudden discontinuation of the medication can cause withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dose must be gradually reduced according to a doctor's direction. Women who are pregnant or breastfeeding should consult their doctor before taking this medication, as it may affect the fetus or newborn. Elderly patients should start at a lower initial dose and carefully monitor for side effects. This medication is known not to have a significant effect on driving or operating machinery; however, caution may be necessary depending on the individual. In cases of overdose, symptoms such as central nervous system symptoms, cardiac arrhythmias, and hypotension may occur, requiring immediate emergency treatment. Finally, this medication is not recommended for use in children and adolescents as safety and efficacy have not been established.

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, perceptual disturbances, tremors, taste disorders, sleep disorders, syncope, serotonin syndrome, movement disorders, motor disturbances, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, epistaxis, nausea, diarrhea, constipation, vomiting, dry mouth, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, hair loss, rash, pruritus, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fractures, palpitations, hypertension, paralysis, extrapyramidal symptoms, migraine, chest pain, drowsiness, aggressive reactions, anorexia, hallucinations, sedation, frequent urination, tremors, dry mouth, abdominal discomfort, anxiety, insomnia, visual hallucinations, retrograde amnesia, epileptic seizures, mania, suicidal impulses, suicidal behavior, hostility, aggression, impulsivity, akathisia, hypomania, mania, hyponatremia, petechiae, purpura, postpartum hemorrhage, serotonin syndrome, dizziness, sleep disorders, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, headache, frequent urination, nausea, headache, dizziness, drowsiness, gastrointestinal disorders, heartburn, sedation, dry mouth, dyspepsia, sweating, frequent urination, sexual dysfunction, tremors, weight gain, abdominal discomfort, anxiety, insomnia, visual hallucinations, fractures, arthralgia, sexual dysfunction, palpitations, hypertension, dizziness, decreased libido, weight gain, withdrawal symptoms, dizziness, sleep disorders, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmia

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

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.