Hanwha Escitalopram Tablet 5mg (Escitalopram Oxalate)

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 increasing the dose of this drug to 20mg, the dose should be increased at intervals of at least 1 week. In general, antidepressants take 2-4 weeks to produce an effect. Even after symptoms have resolved, drug therapy for at least 6 months is needed 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 occurs after approximately 3 months. The safety and efficacy of 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 of patients who responded 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 periodically. Social anxiety disorder is a well-defined diagnostic term for a specific disorder and should not be confused with excessive shyness. Drug therapy should be used only when social anxiety disorder significantly interferes with occupational and social activities. Drug therapy has not been compared with cognitive behavioral therapy. Drug therapy is one part of an overall treatment strategy. (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 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 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 disease, so treatment should be continued for a sufficient period to ensure symptom remission. When this drug is administered long term, its usefulness and dose should be periodically reevaluated 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. 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 possible occurrence of withdrawal symptoms. 5) Switching from MAO inhibitors for the treatment of 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 must be allowed. Conversely, when starting an MAO inhibitor for the treatment of 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 preparations should not be started on this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventional procedures, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue preparations to a patient already receiving this drug. If there are no alternatives to linezolid or intravenous methylene blue preparations and the benefits of treatment with linezolid or intravenous methylene blue preparations 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 preparations administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or intravenous methylene blue preparations, or until 24 hours after the last dose, whichever comes first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue preparations. The risk associated with administration of methylene blue preparations by non-intravenous routes (oral tablets or local injection) or intravenous administration of this drug at 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

This medication is an antidepressant used to treat psychiatric disorders such as Major Depression. This drug can particularly increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so caution must be exercised by physicians when prescribing to this age group. Patients and guardians must closely monitor for worsening depressive symptoms, suicidal thoughts, aggressiveness, rage, and other abnormal behaviors during treatment with this medication. This drug should not be taken with certain medications, particularly MAO inhibitors, Pimozide, or drugs that prolong the QT interval, as serious side effects may occur. Patients with angle-closure glaucoma or a history of glaucoma should be cautious due to the mydriatic effect of this drug potentially increasing intraocular pressure. During the initial 1-2 weeks of administration, side effects such as anxiety, insomnia, dizziness, and nausea may commonly occur, and these symptoms often alleviate over time. This medication may increase the risk of seizures in patients with epilepsy, so those with a history of seizures should consult with their physician. This drug may affect blood sugar control, so diabetic patients must closely monitor for changes in blood sugar levels. When discontinuing the medication, it should not be stopped abruptly; the dosage should be gradually reduced according to a physician's instructions, or withdrawal symptoms may occur. During late pregnancy, this medication may affect the newborn, so pregnant women must consult with their physician before taking it. In breastfeeding cases, as this medication may be transmitted through breast milk, discontinuing breastfeeding or avoiding medication use is recommended. Elderly patients aged 65 and older should start with a lower initial dosage and carefully adjust the dosage. Caution is advised while driving or operating machinery, as this medication may affect one's ability to do so; patients should closely monitor their condition. In cases of overdose, symptoms may include central nervous system abnormalities, cardiac arrhythmias, electrolyte imbalances, etc., requiring immediate medical attention. This drug is not recommended for use in children and adolescents as its safety and efficacy have not been established. There may be an increased risk of bleeding while taking this medication, thus patients with a tendency to bleed or those taking anticoagulants should be cautious. Serotonin syndrome, a serious side effect, may occur, so particular caution is necessary when combined with other serotonergic medications. This medication poses a risk of cardiac arrhythmias in patients with heart disease or prolonged QT interval, so cardiac status should be assessed before administration.

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, perceptual abnormalities, tremors, taste disorders, sleep disorders, fainting, serotonin syndrome, dyskinesia, movement disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval 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 disorder, erectile dysfunction, uterine bleeding, heavy menstruation, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory abnormalities, cough, asthma, shortness of breath, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, frequent urination, tremors, dry mouth, sedation, heartburn, anxiety, visual hallucinations, withdrawal symptoms (dizziness, sleep disorders, anxiety, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual impairment)

This medication must be stored in a tightly closed container to avoid exposure to air or moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle