Medication info

Samsung Escitalopram Tablet 20 mg (Escitalopram Oxalate)

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

MFDS item code 201901928 · Approved 2019.03.29

This product's status changed to Expired on 2024.03.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of major depressive disorder and anxiety disorders (including panic disorder and social anxiety disorder), 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. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day. If increasing the dose of this drug to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to appear. Even after symptoms have resolved, at least 6 months of drug therapy is needed 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. 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 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, 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 therapeutic effect. Long-term treatment in patients who responded to treatment 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 reevaluated 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 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 reevaluate the usefulness of long-term treatment with this drug for each patient. (5) Obsessive-compulsive disorder: The usual dose 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 condition, so this drug should be administered for a sufficient period to ensure recovery from symptoms. When this drug is administered long term, the usefulness and dose should be reevaluated regularly for each patient. 2) Patients with renal impairment No dosage 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 It is recommended to administer an initial dose of 5mg per day for the first 2 weeks. 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 psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, if 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 receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. For patients who require other interventional procedures, including hospitalization, or treatment for a more urgent psychiatric condition, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. 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 drug 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 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 a non-intravenous route (oral tablet or local injection) or with intravenous administration of this drug 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
Samsung Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder and 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 in the treatment of psychiatric disorders such as major depressive disorder, panic disorder (including or not including 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. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day. If increasing the dose of this drug to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to appear. Even after symptoms have resolved, at least 6 months of drug therapy is needed 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. 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 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, 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 therapeutic effect. Long-term treatment in patients who responded to treatment 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 reevaluated 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 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 reevaluate the usefulness of long-term treatment with this drug for each patient. (5) Obsessive-compulsive disorder: The usual dose 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 condition, so this drug should be administered for a sufficient period to ensure recovery from symptoms. When this drug is administered long term, the usefulness and dose should be reevaluated regularly for each patient. 2) Patients with renal impairment No dosage 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 It is recommended to administer an initial dose of 5mg per day for the first 2 weeks. 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 psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, if 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 receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. For patients who require other interventional procedures, including hospitalization, or treatment for a more urgent psychiatric condition, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. 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 drug 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 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 a non-intravenous route (oral tablet or local injection) or with intravenous administration of this drug 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 to treat psychiatric disorders such as major depression. There may be an increase in suicidal thoughts or behavior during the course of treatment, particularly in young patients aged 18 to 24, who require strict monitoring by a physician. This medication should not be taken with certain drugs, especially monoamine oxidase inhibitors (MAOIs) or pimozide, as serious side effects may occur. Additionally, cardiac-related side effects such as QT interval prolongation may occur, so caution is necessary for patients with heart disease or those with a prolonged QT interval. Patients with angle-closure glaucoma should be cautioned as this medication may dilate the pupils and increase intraocular pressure. Initial side effects such as anxiety, insomnia, dizziness, nausea, and headache are common, but these symptoms often subside over time. During treatment, careful observation for worsening symptoms of depression or abnormal behavioral changes such as suicidal thoughts or aggression is essential, and family members or caregivers should closely monitor the patient. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced under a physician's guidance. Women who are pregnant or breastfeeding should consult their doctor before taking this medication, especially during late pregnancy when there may be side effects in the newborn. Elderly patients should start with a lower initial dose compared to younger adults and should carefully adjust their dose. It is advisable not to consume alcohol while taking this medication, and caution is necessary when driving or operating machinery. In case of an overdose, central nervous system symptoms, gastrointestinal disturbances, and arrhythmias may occur, necessitating immediate medical attention. Finally, this medication is not recommended for use in children and adolescents due to insufficient safety and efficacy data.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, 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, perceptual disturbances, tremors, taste disorders, sleep disorders, fainting, serotonin syndrome, abnormal movements, movement disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation on ECG, polymorphic ventricular tachycardia, orthostatic hypotension, sinusitis, yawning, nosebleed, 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 disorder, 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, frequent urination, sedation, polydipsia, emotional instability, hypersensitivity, visual impairment, dizziness, sleep disorders, anxiety, restlessness, tremors, confusion, sweating, diarrhea, palpitations, suicidal tendency, suicidal impulse, hostility, insomnia, agitation, hostility, aggression, impulsivity, akathisia, hypomania, mania, withdrawal symptoms, dizziness, sleep disorders, anxiety, nausea, vomiting, tremors, 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 prevents light exposure. Additionally, it should be kept at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

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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.