Lexacold Tablets 20 mg (Escitalopram Oxalate)

Adult administration

Safety has not been established for doses exceeding 20mg per day. This medicine 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 is to be increased to 20mg, it 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, medication treatment for at least 6 months 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 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 medicine 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 responding patients has been studied for 6 months and should be considered for each patient to prevent relapse. The usefulness 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, after at least 1 week of treatment, the dose may be increased to a maximum of 20mg per day. A long-term treatment study was conducted in patients who responded to 12 weeks of open-label treatment, with 20mg per day administered for at least 6 months. 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. 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, with 10mg or 20mg per day administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic disease; treatment should be continued for a sufficient period to ensure recovery of symptoms. When this medicine is administered 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. Depending on the patient's response, the dose may be increased to 10mg per day. 4) Discontinuation of treatment When discontinuing this medicine, 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 medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days should have elapsed after discontinuing this medicine. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not be started on this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. 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 medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients 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 medicine 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 with intravenous administration of this medicine 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, and caution is required particularly in children, adolescents, and young adults, as there may be an increased risk of suicidal thoughts or behaviors. This medication should not be administered to patients who are allergic to specific components or who are taking MAO inhibitors, and to patients with cardiac conditions related to QT interval prolongation. Patients with closed-angle glaucoma or a history of glaucoma should be cautious, as this medication may dilate the pupil and increase intraocular pressure. During the first 1-2 weeks of treatment, side effects such as anxiety, insomnia, dizziness, and nausea may frequently occur, but symptoms often decrease with time. This medication may cause changes in mental state such as suicidal thoughts, aggression, and hallucinations, so the patient and caregiver should closely monitor the patient during treatment. Sudden discontinuation can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it is advisable to gradually decrease the dosage in consultation with a doctor. Patients with heart disease or those with hypokalemia or hypomagnesemia should have an ECG before and during treatment with this medication. There is a risk of serious side effects known as serotonin syndrome when this medication is combined with other serotoninergic drugs, so it must be discussed with a doctor. During pregnancy, especially in the last trimester, it may affect the newborn, so careful judgment and monitoring are required if used during pregnancy. While breastfeeding, this medication can pass into breast milk, so it is advisable to either stop breastfeeding or avoid taking this medication. Caution is necessary when driving or operating machinery, as individual sensitivity varies. In case of overdose, symptoms may appear in the central nervous system, gastrointestinal tract, and cardiovascular system, and immediate medical attention is required. This medication is not recommended for children and adolescents as its safety and efficacy have not been sufficiently proven. In elderly patients, it is advisable to start with a lower initial dose and to adjust doses carefully.

Thrombocytopenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, loss of appetite, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, nervousness, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremor, taste disorders, sleep disorders, syncope, serotonin syndrome, movement disorders, motor dysfunction, 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 disorders, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, sexual dysfunction, palpitations, paralysis, extrapyramidal disorders, migraine, asthma, dyspnea, fracture, hypertension, chest pain, polyuria, sedation, tremor, dry mouth, heartburn, anxiety, visual hallucinations, dizziness, withdrawal symptoms (dizziness, sleep disorders, anxiety, nausea, vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, mood instability, irritability, visual impairment)

This medication is sensitive to light and should be stored in a tightly closed container that is protected from light. The recommended storage temperature is room temperature between 1°C and 30°C.

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle