Medication info

Escitalopram Tablets 10 mg (escitalopram oxalate)

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

MFDS item code 202001660 · Approved 2020.03.11

This product's status changed to Expired on 2025.03.11. 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 (including panic and social anxiety disorders), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
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. (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 develop. Even after symptoms have resolved, medication treatment for at least 6 months is required to ensure a therapeutic 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 the dose 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 administration of this medication for longer 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 needed 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 chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic 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 benefits 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 treatment trial was conducted in patients who responded to 12 weeks of open-label treatment, administering 20mg per day for at least 6 months. The physician should regularly reassess the benefits of long-term treatment with this medication 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 trial was conducted in patients who responded to 16 weeks of open-label treatment, administering 10mg or 20mg per day for at least 24 weeks. Since obsessive-compulsive disorder is a chronic condition, treatment should be continued for a sufficient period to ensure symptom remission. During long-term use of this medication, the benefit and dose 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 is required 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 medication, 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 At least 14 days should elapse between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication. Conversely, at least 14 days should elapse after discontinuing this medication before starting an MAO inhibitor to treat psychiatric disorders. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients requiring 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 medication. 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 medication may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient 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 medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous 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
IQURE Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, 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 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

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. (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 develop. Even after symptoms have resolved, medication treatment for at least 6 months is required to ensure a therapeutic 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 the dose 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 administration of this medication for longer 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 needed 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 chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic 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 benefits 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 treatment trial was conducted in patients who responded to 12 weeks of open-label treatment, administering 20mg per day for at least 6 months. The physician should regularly reassess the benefits of long-term treatment with this medication 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 trial was conducted in patients who responded to 16 weeks of open-label treatment, administering 10mg or 20mg per day for at least 24 weeks. Since obsessive-compulsive disorder is a chronic condition, treatment should be continued for a sufficient period to ensure symptom remission. During long-term use of this medication, the benefit and dose 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 is required 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 medication, 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 At least 14 days should elapse between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication. Conversely, at least 14 days should elapse after discontinuing this medication before starting an MAO inhibitor to treat psychiatric disorders. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients requiring 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 medication. 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 medication may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient 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 medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous 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 to treat psychiatric disorders such as major depression. This medication may increase the risk of suicidal thoughts and behaviors, particularly in children, adolescents, and young adults aged 18 to 24. Therefore, when administering this medication to patients in this age group, the physician should carefully assess the necessity and risks of treatment. This medication should not be used in combination with certain drugs, especially monoamine oxidase inhibitors (MAOIs), pimozide, and drugs that prolong the QT interval, as these combinations can lead to serious side effects. Patients with glaucoma or a history of angle-closure glaucoma should use this medication with caution due to the risk of increased intraocular pressure from its mydriatic effects. Changes in mental state, such as anxiety, agitation, suicidal thoughts, or aggression, may occur during treatment; therefore, patients and their caregivers should closely monitor for these symptoms and consult medical personnel immediately if any abnormal signs appear. During the initial phase of treatment, side effects such as nausea, insomnia, dizziness, fatigue, and weight changes are common and typically improve over time. Abrupt discontinuation of this medication may cause withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, the dosage should be gradually reduced according to the physician's instructions. Patients with heart conditions or a prolonged QT interval are at risk of arrhythmias; thus, electrocardiograms should be performed before and periodically during treatment to monitor heart status. Women who are pregnant or breastfeeding should consult a physician before using this medication; it is recommended to discontinue breastfeeding while on this medication. Elderly patients may metabolize the drug more slowly; therefore, it is safer to start with a lower initial dose and gradually increase. This medication can cause a serious side effect called serotonin syndrome when combined with other serotonergic medications; thus, symptoms should be monitored closely when taken concurrently. Caution should be exercised when driving or operating machinery considering the effects of this medication on mental function. This medication is not recommended for 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, sensory disturbances, tremors, taste disorders, sleep disturbances, syncope, serotonin syndrome, movement disorders, motor dysfunction, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, ECG QT prolongation, polymorphic ventricular tachycardia, orthostatic hypotension, sinusitis, yawning, epistaxis, 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 disorders, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory abnormalities, cough, sexual dysfunction, palpitations, paralysis, extrapyramidal disorders, migraine, asthma, dyspnea, fractures, hypertension, chest pain, drowsiness, aggressive reactions, anorexia, visual disturbances, sedation, polyuria, tremors, dry mouth, heartburn, anxiety, insomnia, hallucinations, emotional instability, irritability, visual impairment, withdrawal symptoms (dizziness, sleep disturbances, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations)

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

Storage

This medication should be stored in a sealed container as it is sensitive to air and moisture. It is important to maintain a storage temperature between 1°C and 30°C to preserve the medication's effectiveness and safety.

Appearance and packaging

Appearance

white, rectangular 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.