Medication info
EDPA Tablet 20 mg (Escitalopram Oxalate)

EDPA Tablet 20 mg (Escitalopram Oxalate)

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

MFDS item code 201404823 · Approved 2014.10.21 · Insurance code 645305060

Summary

Main use
Treatment of depressive disorders, anxiety disorders (including panic and social anxiety), and obsessive-compulsive disorder
Who uses it
Adults
Adult dosage
The safety of doses exceeding 20mg per day has not been established. This medication is administered once daily, in the morning or evening, with or without food. 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 to 20mg, allow an interval of at least 1 week before increasing the dose. In general, 2-4 weeks are required for antidepressant effects to become apparent. Even after symptoms have resolved, drug therapy for at least 6 months is required to ensure a sustained therapeutic effect. Panic disorder with or without agoraphobia: The recommended initial dose is 5mg per day for 1 week, followed by an increase to 10mg per day. The dose may be increased to a maximum of 20mg per day according to the patient's response. The maximum effect is achieved after approximately 3 months. The safety and efficacy of long-term administration of this medication 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. Social anxiety disorder: The usual dose is 10mg once daily. In general, 2-4 weeks are required for symptom improvement. 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 chronic condition; 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 for each patient to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. Generalized anxiety disorder: The initial dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day after at least 1 week of treatment, according to the patient's response. 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 medication for each patient. 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, with 10mg or 20mg per day administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition; treatment should continue for a sufficient period to ensure symptom remission. If this medication is administered long term, the benefit and dose should be regularly reassessed for each patient. No dose adjustment is required in patients with mild or moderate renal impairment. Use with caution in patients with severe renal impairment (CLCR < 30㎖/min). An initial dose of 5mg per day for the first 2 weeks is recommended. The dose may be increased to 10mg per day according to the patient's response. If treatment with this medication is discontinued, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. When switching from an MAO inhibitor used to treat psychiatric disorders to treatment with this medication, an interval of at least 14 days must elapse. Conversely, at least 14 days must elapse after discontinuing this medication before starting an MAO inhibitor to treat psychiatric disorders. 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 medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablets or local injection) or with intravenous administration of this medication at a dose of 1mg/kg or less is unclear.

Ingredients

Manufacturer
Hanlim Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of depressive disorders, anxiety disorders (including panic and social anxiety), 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 (with or without agoraphobia), social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder.

Dosage and Administration

Adult dosage

The safety of doses exceeding 20mg per day has not been established. This medication is administered once daily, in the morning or evening, with or without food. 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 to 20mg, allow an interval of at least 1 week before increasing the dose. In general, 2-4 weeks are required for antidepressant effects to become apparent. Even after symptoms have resolved, drug therapy for at least 6 months is required to ensure a sustained therapeutic effect. Panic disorder with or without agoraphobia: The recommended initial dose is 5mg per day for 1 week, followed by an increase to 10mg per day. The dose may be increased to a maximum of 20mg per day according to the patient's response. The maximum effect is achieved after approximately 3 months. The safety and efficacy of long-term administration of this medication 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. Social anxiety disorder: The usual dose is 10mg once daily. In general, 2-4 weeks are required for symptom improvement. 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 chronic condition; 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 for each patient to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. Generalized anxiety disorder: The initial dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day after at least 1 week of treatment, according to the patient's response. 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 medication for each patient. 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, with 10mg or 20mg per day administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition; treatment should continue for a sufficient period to ensure symptom remission. If this medication is administered long term, the benefit and dose should be regularly reassessed for each patient. No dose adjustment is required in patients with mild or moderate renal impairment. Use with caution in patients with severe renal impairment (CLCR < 30㎖/min). An initial dose of 5mg per day for the first 2 weeks is recommended. The dose may be increased to 10mg per day according to the patient's response. If treatment with this medication is discontinued, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. When switching from an MAO inhibitor used to treat psychiatric disorders to treatment with this medication, an interval of at least 14 days must elapse. Conversely, at least 14 days must elapse after discontinuing this medication before starting an MAO inhibitor to treat psychiatric disorders. 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 medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablets or local injection) or with intravenous administration of this medication 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. Care should be taken as there is an increased risk of suicidal thoughts or behaviors in children, adolescents, and young adults. Patients with a known allergy to this medication's components or who are taking MAO inhibitors should not use this medication. Patients with closed-angle glaucoma or a history of glaucoma should be cautious as there may be an increased risk of intraocular pressure when taking this medication. Initial use may cause side effects such as anxiety, insomnia, and dizziness, which often improve over time. This medication can affect heart rhythm, so patients with QT interval prolongation or heart disease should consult a physician. During treatment, it is important to closely monitor for changes in mental state, such as suicidal thoughts, aggression, and anxiety, and it is also important for family members or caregivers to observe these changes. Abruptly stopping the medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced under a doctor’s guidance. This medication may interact with other drugs, so patients should inform their doctor or pharmacist of any other medications they are taking. If pregnant or breastfeeding, a consultation with a physician is recommended before use, and nursing mothers are advised to discontinue breastfeeding while taking this medication. Elderly patients should start with a lower dosage than usual for safety. Caution is advised while driving or operating machinery, as individual responses may vary. Keep this medication out of reach of children and do not transfer it to another container. In case of overdose, contact a medical institution immediately for appropriate treatment.

Side effects

thrombocytopenia, anaphylactic reaction, inappropriate secretion of antidiuretic hormone, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, loss of appetite, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, nervousness, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, altered perception, tremor, taste disorder, sleep disorder, syncope, serotonin syndrome, movement disorder, motor dysfunction, 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, thirst, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased perspiration, urticaria, 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, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, drowsiness, aggressive reactions, loss of appetite, hallucinations, sexual dysfunction, insomnia, anxiety, restlessness, impulsiveness, akathisia, hypomania, mania, dizziness, sensory disturbances, sleep disorders, nausea, vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations

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 container that protects it from light. It is also recommended to store it at room temperature between 1°C and 30°C. Proper storage helps maintain the medication's effectiveness and ensures its safe use.

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.