Escitalopram Oxalate 5 mg Tablets

Adult administration

Safety has not been established for doses exceeding 20mg per day. This drug is administered once daily in the morning or evening, regardless of 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 drug is to be increased to 20mg, it should be increased at intervals of at least 1 week. In general, 2-4 weeks are required for antidepressant effects to become apparent. Even after symptoms have resolved, drug treatment for at least 6 months 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. The dose may be increased to a maximum of 20mg per day according to the patient's response. The maximum effect occurs 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 required 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 a therapeutic effect. Long-term treatment of patients who responded was 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 regularly. (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 administration for at least 1 week. A long-term administration trial 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 reassess the usefulness of long-term treatment with this drug 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 administration trial 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. Since obsessive-compulsive disorder is a chronic disease, treatment should be continued for a sufficient period to ensure recovery from symptoms. When this drug is administered long term, its usefulness and dose should be regularly 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. The dose may be increased to 10mg per day according to the patient's response. 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, when 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 be started on this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, 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 the benefits of treatment with linezolid or intravenous methylene blue 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 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 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 non-intravenous routes (oral tablets or local injection) or intravenous administration of this drug at a dose of 1mg/kg or less is unclear.

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric illnesses; therefore, careful assessment of the necessity for treatment in this age group is required. During the treatment, if there are unusual behavioral changes such as symptoms of depression, suicidal tendencies, aggression, or anger, consult a healthcare professional immediately, and family or guardians should carefully monitor the patient. This medication should not be used if there is an allergy to the active ingredient or other ingredients, or if the patient is currently taking MAO inhibitors, pimozide, or medications that prolong the QT interval. Patients with closed-angle glaucoma or a history of glaucoma should use this medication with caution as it may dilate the pupils and increase intraocular pressure. In the initial 1-2 weeks of treatment, side effects such as anxiety, insomnia, dizziness, nausea, and diarrhea may commonly occur, but they generally decrease over time. This medication can affect heart rhythm, so patients with heart diseases or those with QT interval prolongation may need to undergo an ECG before administration. Blood sugar control may change during antidepressant treatment, so diabetic patients should closely monitor their blood sugar levels. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disorders; therefore, the dosage should be gradually reduced according to a doctor’s advice. Taking it with other serotonin-active medications may cause a serious side effect called serotonin syndrome, thus caution is needed when combined. If pregnant or breastfeeding, consultation with a doctor is required as the use of this medication may affect the newborn, and it is advised to avoid using it while breastfeeding or to discontinue breastfeeding. Elderly patients should start with a lower initial dose and adjust as needed for safety. Caution is advised when driving or operating machinery; users should check their condition after taking this medication and avoid hazardous activities. In the case of overdose, symptoms may occur in the central nervous system, gastrointestinal system, and cardiovascular system, so immediate medical attention is necessary for appropriate treatment. This medication should be kept out of reach of children and it is advisable not to transfer it to another container.

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, nervousness, 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 disorders, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation, polymorphic ventricular tachycardia, orthostatic hypotension, sinusitis, yawning, nosebleed, nausea, diarrhea, constipation, vomiting, dry mouth, gastrointestinal bleeding, hepatitis, abnormal liver function tests, excessive sweating, urticaria, hair loss, rash, itching, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculation disorders, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, frequent urination, tremors, dry mouth, sedation, heartburn, anxiety, visual disturbances, dizziness, drowsiness

This medication should be stored in a tightly closed container to protect it from air or moisture, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and allows for safe use.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle