Sandoz Escitalopram Tablets 10 mg (Escitalopram Oxalate)

Adult dosage

Safety has not been established for doses exceeding 20mg per day. This medication is administered once daily in the morning or evening, with or without food. (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 increasing the dose of this medication to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to occur. Even after symptoms have resolved, at least 6 months of drug treatment 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 medication 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in patients who responded has been studied for 6 months and should be considered on an individual basis to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. Social anxiety disorder is a well-defined diagnostic term for a specific disorder and should not be confused with excessive shyness. Drug treatment should be given only when social anxiety disorder significantly interferes with occupational and social activities. Comparison of drug treatment with cognitive behavioral therapy has not been evaluated. Drug treatment 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 administration 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 medication 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 administration 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 condition, so treatment should be continued for a sufficient period to ensure symptom remission. When this medication is administered long term, its usefulness and dosage should be periodically reassessed for each patient. 2) Patients with renal impairment No dose adjustment is necessary for 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. The dose may be increased to 10mg per day depending on the patient's response. 4) Discontinuation When discontinuing this medication, 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 medication, 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 medication. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication 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, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. 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 medication 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 medication 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 medication at 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with such use.

This medication may increase the risk of suicidal thoughts and behaviors in young people with major depressive disorder or other psychiatric conditions, and therefore healthcare providers should carefully consider the necessity and risks of treatment. This medication can be dangerous when taken with certain drugs, particularly for patients taking MAO inhibitors or pimozide, and should be avoided in these cases. Patients with glaucoma or a history of glaucoma should be cautious as this medication may increase intraocular pressure due to its mydriatic effect. During the first 1-2 weeks of administration, abnormal reactions such as anxiety, insomnia, and dizziness may occur, but these typically decrease over time. This medication can cause various side effects affecting the blood, mental state, nerves, gastrointestinal system, skin, and heart; therefore, immediate consultation with healthcare professionals is necessary if symptoms appear. Particularly, mental changes such as suicidal thoughts or behaviors, aggression, and hallucinations should be closely monitored, and family or guardians should also observe. Abrupt discontinuation during treatment can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disorders; therefore, dosage should be gradually reduced after consultation with a physician. Patients with heart disease or those with prolonged QT intervals are at risk of cardiac arrhythmias when taking this medication; therefore, regular ECG monitoring is necessary. If pregnant or breastfeeding, this medication may affect the fetus or newborn, so consultation with a physician before taking it is essential. It is advisable not to take this medication with alcohol, and caution should be exercised when combining it with other serotonergic medications due to the risk of serotonin syndrome. Elderly patients should start with a lower initial dose, and patients with impaired liver function may also require dose adjustment. It is recommended not to use this medication in children and adolescents, as its safety and efficacy have not been established. Caution is necessary when driving or operating machinery, and if any unusual symptoms occur after medication intake, activities should be limited. In case of overdose, symptoms affecting the central nervous system, gastrointestinal system, heart, etc., may arise, so it is important to seek immediate medical attention for appropriate treatment. This medication should be kept out of reach of children, and it is safer not to transfer it to other containers.

Thrombocytopenia, anaphylactic reactions, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, nervousness, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disturbances, sleep disorders, syncope, serotonin syndrome, movement abnormalities, motor disorders, convulsions, 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 disorders, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fractures, palpitations, hypertension, paralysis, extrapyramidal disorders, migraine, chest pain, frequent urination, tremor, dry mouth, heartburn, sedation, anxiety, visual hallucinations, retrograde anxiety, epileptic seizures, mania, withdrawal symptoms, dizziness, sleep disorders, anxiety, tremors, confusion, sweating, diarrhea, emotional instability, irritability, visual impairment, hypokalemia, hypomagnesemia, sexual dysfunction, persistent sexual dysfunction

This medication is sensitive to light and should be stored in a container that does not allow light to enter. Additionally, it should be stored at room temperature, maintaining a temperature between 1 to 30 degrees. Proper storage will maintain the effectiveness and safety of the medication.

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle