Medication info
Shinshin Escitalopram Tablets 20 mg (Escitalopram Oxalate)

Shinshin Escitalopram Tablets 20 mg (Escitalopram Oxalate)

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

MFDS item code 201903129 · Approved 2019.05.15

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 drug is administered once daily, in the morning or evening, with or without food. 1) Adults (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 the dose of this drug 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, at least 6 months of drug therapy is required to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended that an initial dose of 5mg per day be administered 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 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 disease with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in patients who respond 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 reassessed periodically. (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 administration for at least 1 week. A long-term administration 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 periodically reassess 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 administration 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; this drug should be administered for a sufficient period to ensure recovery from symptoms. For long-term administration of this drug, the benefit and dose should be periodically reassessed for each patient. 2) Patients with renal impairment No dose adjustment is required 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 It is recommended that an initial dose of 5mg per day be administered for the first 2 weeks. Depending on the patient's response, the dose may be increased to 10mg per day. 4) Discontinuation 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 for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used for the treatment of psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 14 days should 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. In patients requiring more urgent treatment for a psychiatric condition, including hospitalization and other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this drug. If there are no alternative drugs for 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 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 occurs first. Treatment with this drug may be restarted 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 intravenous administration of this drug at a dose of 1mg/kg or less is unclear.

Ingredients

Manufacturer
Shinshin Pharmaceuticals 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 for the treatment of panic disorder, with or without 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, with or without food. 1) Adults (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 the dose of this drug 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, at least 6 months of drug therapy is required to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended that an initial dose of 5mg per day be administered 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 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 disease with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in patients who respond 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 reassessed periodically. (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 administration for at least 1 week. A long-term administration 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 periodically reassess 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 administration 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; this drug should be administered for a sufficient period to ensure recovery from symptoms. For long-term administration of this drug, the benefit and dose should be periodically reassessed for each patient. 2) Patients with renal impairment No dose adjustment is required 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 It is recommended that an initial dose of 5mg per day be administered for the first 2 weeks. Depending on the patient's response, the dose may be increased to 10mg per day. 4) Discontinuation 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 for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used for the treatment of psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 14 days should 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. In patients requiring more urgent treatment for a psychiatric condition, including hospitalization and other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this drug. If there are no alternative drugs for 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 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 occurs first. Treatment with this drug may be restarted 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 intravenous administration of this drug at a dose of 1mg/kg or less is unclear.

Precautions

This medication is an antidepressant used for the treatment of mental disorders such as depression. During treatment with this drug, particularly young people between the ages of 18 and 24 may have an increased risk of suicidal thoughts or behaviors; hence, it should be used with caution and under medical advice. Patients with an allergy to any component of this drug or who are currently taking certain medications, such as MAO inhibitors, should not use this drug. Patients with a history of angle-closure glaucoma or glaucoma should be cautious, as this drug may dilate pupils and elevate intraocular pressure. Side effects such as anxiety, insomnia, and dizziness may occur when starting this medication, but they usually decrease over time. This drug can cause various side effects including blood pressure changes, gastrointestinal issues, skin rashes, and sexual dysfunction; if symptoms are severe, consultation with a physician is advised. Especially, abruptly discontinuing this drug may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be decreased gradually according to the physician's instructions. Additionally, this drug may affect heart rhythms; therefore, patients with heart disease or those with QT interval prolongation should undergo regular ECG monitoring. Interactions may occur when taken with other medications, so it is essential to inform healthcare personnel about any other drugs being taken. Women who are pregnant or breastfeeding should consult a doctor, as this drug may impact the fetus or newborn. It is not recommended for children or adolescents as safety and efficacy have not been established. Elderly patients should start at a lower dosage, and caution is advised while driving or operating machinery. When storing this drug, keep it out of reach of children, and do not transfer it to another container.

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, neuroticism, panic attack, confusional state, aggression, depersonalization, hallucinations, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, syncope, serotonin syndrome, dyskinesia, movement disorders, convulsions, psychomotor agitation, mydriasis, visual disturbances, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmias, orthostatic hypotension, sinusitis, yawning, nosebleed, nausea, diarrhea, constipation, vomiting, xerostomia, 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, persistent erection, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory abnormalities, cough, asthma, shortness of breath, fractures, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, frequent urination, tremor, emotional instability, hyperreactivity, visual impairment, insomnia, aggressive reactions, anorexia, visual hallucinations, sedation, heartburn, dry mouth, sweating, weight gain, nausea, abdominal pain, drowsiness, sexual dysfunction, dizziness, decreased libido, weight gain, headache, frequent urination, dizziness, somnolence, gastrointestinal disturbances, nausea, vomiting, diarrhea, tremors, confusion, sweating, headache, diarrhea, palpitations, sensory abnormalities, sleep disorders, anxiety, agitation, panic attacks, confusional state, aggression, depersonalization, hallucinations, mania, suicidal thoughts, suicidal behavior

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 protects it from light. Additionally, it is safe to store the drug at room temperature, specifically between 1 to 30 degrees Celsius. Following these conditions will help maintain the drug's effectiveness and safety.

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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.