Medication info
Shinshin Escitalopram Tablet 10mg (Escitalopram Oxalate)

Shinshin Escitalopram Tablet 10mg (Escitalopram Oxalate)

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

MFDS item code 201903130 · Approved 2019.05.15 · Insurance code 643802930

Summary

Main use
Treatment of major depressive disorder, 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 medicine is administered once daily in the morning or evening, without regard to meals. 1) Adults (1) 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 the dose of this medicine is to be increased to 20mg, it 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, drug treatment for at least 6 months is needed 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 it 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 appears after about 3 months. The safety and efficacy of treatment with this medicine for more than 10 weeks in 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, 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure the treatment effect. Long-term treatment in patients who respond has been studied for 6 months, and should be considered on an individual basis to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. Social anxiety disorder is a well-defined diagnostic term for a specific disorder and should not be confused with excessive shyness. Drug treatment should be given only when social anxiety disorder significantly interferes with occupational and social activities. Drug treatment has not been compared with cognitive behavioral therapy. Drug treatment is one part of an overall treatment strategy. (4) Generalized anxiety disorder: The initial dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response, after treatment for at least 1 week. A long-term treatment trial administering 20mg per day for at least 6 months was conducted in patients who responded to 12 weeks of open-label treatment. 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 according to the patient's response. A long-term treatment trial administering 10mg or 20mg per day for at least 24 weeks was conducted in patients who responded to 16 weeks of open-label treatment. Obsessive-compulsive disorder is a chronic condition; therefore, treatment should be continued for a sufficient period to ensure symptom resolution. When this medicine is used long term, its usefulness and dosage should be reassessed regularly 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 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. 4) Discontinuation of treatment If treatment with this medicine is discontinued, 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 after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this product. Conversely, at least 14 days should elapse after discontinuing this product before starting an MAO inhibitor for the treatment of psychiatric disorders. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this product because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this product. If there is no alternative to linezolid or intravenous methylene blue 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 product 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 starting linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this product may be restarted 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 product 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
Shinshin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, 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 major depressive disorder, panic disorder, social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder. It specifically helps alleviate anxiety and depressive symptoms caused by these mental health issues. It contributes to improving the patient's symptoms and enhancing the quality of life.

How it is given

Adult administration

Safety has not been established for doses exceeding 20mg per day. This medicine is administered once daily in the morning or evening, without regard to meals. 1) Adults (1) 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 the dose of this medicine is to be increased to 20mg, it 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, drug treatment for at least 6 months is needed 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 it 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 appears after about 3 months. The safety and efficacy of treatment with this medicine for more than 10 weeks in 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, 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure the treatment effect. Long-term treatment in patients who respond has been studied for 6 months, and should be considered on an individual basis to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. Social anxiety disorder is a well-defined diagnostic term for a specific disorder and should not be confused with excessive shyness. Drug treatment should be given only when social anxiety disorder significantly interferes with occupational and social activities. Drug treatment has not been compared with cognitive behavioral therapy. Drug treatment is one part of an overall treatment strategy. (4) Generalized anxiety disorder: The initial dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response, after treatment for at least 1 week. A long-term treatment trial administering 20mg per day for at least 6 months was conducted in patients who responded to 12 weeks of open-label treatment. 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 according to the patient's response. A long-term treatment trial administering 10mg or 20mg per day for at least 24 weeks was conducted in patients who responded to 16 weeks of open-label treatment. Obsessive-compulsive disorder is a chronic condition; therefore, treatment should be continued for a sufficient period to ensure symptom resolution. When this medicine is used long term, its usefulness and dosage should be reassessed regularly 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 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. 4) Discontinuation of treatment If treatment with this medicine is discontinued, 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 after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this product. Conversely, at least 14 days should elapse after discontinuing this product before starting an MAO inhibitor for the treatment of psychiatric disorders. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this product because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this product. If there is no alternative to linezolid or intravenous methylene blue 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 product 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 starting linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this product may be restarted 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 product 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. Careful judgment by a physician is required when prescribing this medication to children, adolescents, and young adults due to the increased risk of suicidal impulses or actions. All patients taking this medication should be closely observed for changes in suicidal tendencies or behaviors during the initial treatment and dosage changes, and family members or caretakers should also monitor the patient’s condition. This medication should not be taken in conjunction with certain drugs, especially monoamine oxidase inhibitors (MAOIs) or pimozide, as this could lead to severe side effects. Additionally, patients with heart problems or prolonged QT interval need to be cautious as this medication may pose a risk of cardiac arrhythmias. Patients with eye health issues or a history of angle-closure glaucoma should be careful, as this medication can dilate the pupils and increase intraocular pressure. Various side effects may appear during the initial 1-2 weeks of treatment, such as anxiety, insomnia, dizziness, nausea, weight change, and sexual dysfunction, most of which typically subside over time. Particularly, this medication can induce a serious condition known as serotonin syndrome, so caution is advised when used in combination with other serotonin acting medications. If treatment is suddenly discontinued, withdrawal symptoms such as dizziness, anxiety, and sleep disorders may occur, so the dosage should be gradually reduced under a physician's guidance. Pregnant or nursing women should be cautious regarding the use of this medication, particularly in the later stages of pregnancy, as side effects may present in newborns. Elderly patients should start at a lower initial dose, and those with heart disease or electrolyte imbalance are recommended to undergo cardiac evaluation before treatment. Caution is advised for activities such as driving or operating machinery depending on symptoms. Overdose may result in central nervous system symptoms, gastrointestinal disturbances, and cardiac arrhythmias, and immediate medical intervention is necessary. Finally, the safety and efficacy of this medication in children have not been established, and its use is not recommended.

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, hyperesthesia, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, paresthesia, tremor, taste disorder, sleep disorder, syncope, serotonin syndrome, dyskinesia, movement disorder, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, nosebleed, nausea, diarrhea, constipation, vomiting, polydipsia, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, hair loss, rash, pruritus, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculatory dysfunction, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbance, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, aggressive response, visual hallucinations, sedation, tremors, frequency of urination, dry mouth, heartburn, insomnia, emotional lability, irritability, visual impairment, coma, hypotension, agitation, dystonia, tonic muscle spasms, partial seizures, coordination disorders, sweating, flushing, high fever, tremors, seizures, confusion, nausea, vomiting, diarrhea, dizziness, sleep disorder, anxiety, tremors, confusion, sweating, headache, diarrhea, palpitations, sensory disturbance, withdrawal symptoms

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 does not allow light to enter. Additionally, it is important to store the medication at room temperature between 1 and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White oval film-coated tablets

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.