Medication info
Zepra 10 mg Tablet (Escitalopram Oxalate)

Zepra 10 mg Tablet (Escitalopram Oxalate)

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

MFDS item code 201708465 · Approved 2017.12.21 · Insurance code 645405130

Summary

Main use
Treatment of depressive disorders, anxiety disorders (including panic disorder and social anxiety disorder), 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, with or without food. 1) Adults (1) Major depressive disorder: The usual dosage 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 the effects of antidepressants to become apparent. Even after symptoms have resolved, drug therapy for at least 6 months is required to ensure a sustained treatment effect. (2) Panic disorder with or without agoraphobia: The recommended starting dosage is 5mg per day 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 dosage 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 treatment effect. Long-term treatment in patients who responded was 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 starting dosage 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, 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 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, in which 10mg or 20mg per day was 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 regularly reassessed for each 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 A starting 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 should be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed since discontinuation of this drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue 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 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 comes first. Treatment with this drug may be resumed 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 with intravenous administration of this drug at a dose of 1mg/kg or less, is unclear.

Ingredients

Manufacturer
Jeil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of depressive disorders, anxiety disorders (including 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 various mental health issues including major depressive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder. It is particularly effective for panic disorders whether accompanied by agoraphobia or not. It is also helpful for patients with social phobia and generalized anxiety disorder, alleviating anxiety symptoms. It assists in the improvement of symptoms in the treatment of obsessive-compulsive disorder. This medication is used with the aim of overall mental stability and symptom relief.

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, with or without food. 1) Adults (1) Major depressive disorder: The usual dosage 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 the effects of antidepressants to become apparent. Even after symptoms have resolved, drug therapy for at least 6 months is required to ensure a sustained treatment effect. (2) Panic disorder with or without agoraphobia: The recommended starting dosage is 5mg per day 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 dosage 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 treatment effect. Long-term treatment in patients who responded was 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 starting dosage 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, 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 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, in which 10mg or 20mg per day was 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 regularly reassessed for each 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 A starting 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 should be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed since discontinuation of this drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue 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 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 comes first. Treatment with this drug may be resumed 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 with 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. While taking this medication, the risk of suicidal thoughts or actions may increase, especially in adolescents and young adults aged 18 to 24, so patients and caregivers should closely monitor during the initial treatment period. This medication should not be taken with certain drugs, especially MAO inhibitors or Pimozide, as this can cause serious side effects, and it is crucial to consult a doctor. Caution is required when using this medication for glaucoma patients or those with a history of glaucoma as it may increase ocular pressure. During the first 1-2 weeks of treatment, various side effects such as nausea, insomnia, dizziness, and changes in appetite may occur, but these symptoms often improve over time. This medication can affect heart rhythm, so patients with a prolonged QT interval or those taking related medications should be careful. During treatment, mental symptoms such as anxiety, agitation, aggression, or impulsivity may arise, so it is essential to consult a healthcare professional immediately if such changes occur. Sudden discontinuation of this medication can result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it should be gradually reduced under a doctor’s direction. If pregnant or breastfeeding, consultation with a doctor is necessary as this medication may affect the baby, especially in the later stages of pregnancy. In elderly patients, it is safer to start with a reduced dosage, and diabetic patients who require blood sugar control should closely monitor their blood glucose levels. Caution may be necessary when driving or operating machinery, so patients should assess their condition after taking the medication. In case of overdose, serious issues may arise in the central nervous system, heart, or gastrointestinal tract, thus emergency treatment is required. This medication is not recommended for children and adolescents as its safety and efficacy have not been established. When storing this medication, keep it out of reach of children, and it is advisable not to transfer it to other containers.

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, neuromuscular irritability, panic attacks, confusion, aggression, depersonalization, hallucination, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, paresthesia, tremor, taste disorder, sleep disorder, syncope, serotonin syndrome, movement disorders, motor dysfunction, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation on ECG, 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, priapism, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, tremor, dry mouth, polyuria, sedation, heartburn, anxiety, hallucination, dizziness, sensory disturbances, sleep disorders, agitation, confusion, sweating, diarrhea, emotional instability, hyperreactivity, visual impairment, hypokalemia, hypomagnesemia, hypotension

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

Storage

This medication is sensitive to light, so it should be stored in a container that does not allow light to enter. Additionally, it is best to keep the medication at room temperature, which is between 1°C and 30°C, to maintain its effectiveness.

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.