Ascadin Tablet (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 the dose 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 become apparent. Even after symptoms have resolved, drug therapy for at least 6 months is required to ensure a sustained 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 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 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 treatment effect. Long-term treatment in responding patients 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 regularly. 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 given 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 at least 1 week of treatment. A long-term study was conducted in patients who responded to 12 weeks of open-label treatment, administering 20mg per day for at least 6 months. The physician should regularly 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 study was conducted in patients who responded to 16 weeks of open-label treatment, administering 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, and 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 reevaluated for each patient. 2) Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severe renal impairment (CLCR < 30㎖/min). 3) Patients with hepatic impairment It is recommended to administer an initial dose of 5mg per day 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 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 must 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 start this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent 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 drug. 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 considered to outweigh the risk of serotonin syndrome, this drug may be stopped 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 risks associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection), or with intravenous administration of this drug at doses of 1mg/kg or less, are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders. Therefore, when administering to patients in this age group, the physician must carefully assess the risks and benefits. Changes in suicidal tendencies or behavior should be closely monitored after the treatment begins in all age groups, and family members or caregivers should also closely observe the patient. This medication should not be used in patients with known allergies to certain components or those taking MAO inhibitors, pimozide, and drugs that prolong the QT interval. Caution is required in patients with closed-angle glaucoma or a history of glaucoma, as this drug may dilate pupils and increase intraocular pressure. During the first 1-2 weeks of administration, various side effects such as anxiety, insomnia, dizziness, and changes in appetite may occur, but most will decrease over time. This medication can affect blood coagulation, so patients with bleeding tendencies or those taking anticoagulants should be cautious. Additionally, sudden discontinuation of the medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, and the dosage should be gradually reduced in consultation with a physician. Patients with heart disease or those with a prolonged QT interval may have an increased risk of cardiac arrhythmias, and an ECG may be necessary before starting the medication. During pregnancy, the use of this medication may impact the newborn, so it should be administered only after consulting with a physician, and if breastfeeding, either the breastfeeding should be discontinued or the administration avoided. Elderly patients should start with a lower initial dose and be monitored closely. This medication may cause a severe side effect called serotonin syndrome when taken with other serotonergic drugs, so caution is necessary when used in combination. It may affect mental alertness while driving or operating machinery, so caution is advised. In case of overdose, symptoms can occur in the central nervous system, cardiovascular system, and gastrointestinal tract, requiring immediate emergency treatment. This medication should be kept out of the reach of children and transferring to other containers should be avoided.

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 thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbance, tremor, taste disturbance, sleep disorder, syncope, serotonin syndrome, dyskinesia, movement disorder, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation, polymorphic ventricular tachycardia, orthostatic hypotension, sinusitis, yawning, epistaxis, nausea, diarrhea, constipation, vomiting, polydipsia, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, hair loss, rash, itching, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculation disorder, impotence, 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, frequency of urination, tremor, emotional instability, hyperirritability, visual impairment, insomnia, excitement, hostility, impulsivity, hypomania, mania, dizziness, sleep disorders, anxiety, tremor, confusion, diarrhea

This medication is sensitive to light; therefore, it must be stored in a light-blocking container. Additionally, to ensure the safety of the medication, it is important to store it at room temperature, between 1 degree to 30 degrees Celsius.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle