Nexarone Tablet 5 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, regardless of meals. (1) Major depressive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day depending on the patient's response. If the dose is to be increased to 20mg, it should be increased at intervals of at least 1 week. Antidepressant effects generally take 2-4 weeks to develop. Even after symptoms have resolved, drug 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. The dose may be increased to a maximum of 20mg per day depending on the patient's response. 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 reevaluate each patient to determine the need for continued treatment. (3) Social anxiety disorder: The usual dose is 10mg once daily. Improvement in symptoms generally takes 2-4 weeks. Thereafter, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day depending on 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 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. (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 treatment 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 medicine 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 depending on the patient's response. A long-term treatment 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; treatment should be continued for a sufficient period to ensure recovery from symptoms. When this medicine is used long term, the usefulness and dosage should be regularly reevaluated for each patient. 2) Patients with renal impairment No dosage 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. The dose may be increased to 10mg per day depending on the patient's response. 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 must 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 start this medicine because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment 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, in a specific 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. 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 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 nonintravenous routes (oral tablets or local injection) or intravenous administration of this medicine at a dose of 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 may increase the risk of suicidal thoughts or behaviors when used in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders. This medication should not be administered in patients taking certain drugs, particularly MAO inhibitors or pioglitazone, or drugs that prolong the QT interval. Patients with a history of glaucoma or angle-closure glaucoma should use this medication cautiously due to the potential increase in intraocular pressure from its mydriatic effects. When this medication is initially administered, symptoms such as anxiety, insomnia, and restlessness may appear, and the patient's condition should be closely monitored during the first few weeks of treatment. Abrupt discontinuation may trigger withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, the dosage should be gradually reduced under a physician's guidance. Patients with heart disease or a risk of QT interval prolongation may require an ECG prior to administration due to the potential for cardiac arrhythmias. This medication can cause sexual dysfunction, and patients should consult healthcare providers if these symptoms persist. During pregnancy, especially in the late stages, there could be effects on the newborn, so pregnant women should carefully consider the need and risks of administration. During breastfeeding, this medication may be transmitted through breast milk; therefore, it is recommended to discontinue breastfeeding or avoid administration. It is advisable not to take this medication with alcohol, and caution is required when driving or operating machinery. In the case of overdose, symptoms may occur related to the central nervous system, gastrointestinal system, and cardiovascular system, necessitating immediate medical attention. Store this medication out of reach of children, and do not transfer it to another container for safety.

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 disturbances, tremor, taste disorders, sleep disturbances, syncope, serotonin syndrome, movement disorders, dyskinesia, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmias, 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, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fractures, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, frequent urination, tremors, dry mouth, sedation, heartburn, anxiety, visual hallucinations, withdrawal symptoms (dizziness, sleep disturbances, anxiety, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual impairment), hypokalemia, hypomagnesemia

Store this medication in a tightly closed container to protect it from air and moisture, at room temperature between 1 to 30 degrees Celsius. This will help maintain the efficacy of the medication safely.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle