Sandoz Escitalopram Tablets 5 mg

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) 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 increasing the dose of this medicine to 20mg, the increase should be made at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressants to take effect. 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. 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment of patients who respond has been studied for 6 months; it should be considered for each individual patient 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. Drug treatment has not been compared with cognitive behavioral therapy. 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 treatment study 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 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, in which 10mg or 20mg per day was administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition; treatment should be continued for a sufficient period to ensure symptom recovery. If this medicine is administered long term, the usefulness and dose should be regularly reassessed for each individual 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. 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 must be observed. 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 treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and 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 there is no alternative to linezolid or intravenous methylene blue, 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 medicine may be stopped 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 risks associated with methylene blue administered by nonintravenous routes (oral tablets or local injection), or with intravenous administration of this medicine at a dose 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 is an antidepressant used to treat psychiatric disorders such as major depression. Caution should be exercised, especially in children, adolescents, and young adults, as there may be an increased risk of suicidal thoughts. This medication should not be administered to patients with allergies to specific ingredients or those currently taking MAO inhibitors, pimozide, or drugs that cause QT interval prolongation. Patients with glaucoma or a history of glaucoma should be careful, as this medication may cause pupillary dilation and increase intraocular pressure. Side effects such as anxiety, insomnia, dizziness, nausea, headache may commonly occur during the first 1-2 weeks of treatment but tend to decrease over time. This medication can cause changes in mental symptoms, such as suicidal thoughts or behaviors, aggression, and anxiety, so patients and caregivers should closely monitor for these changes. A sudden discontinuation of the medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, the dosage should be gradually reduced. Patients with heart disease or those at risk of QT interval prolongation require cardiac monitoring, and attention should also be given to electrolyte imbalances such as hypokalemia or hypomagnesemia. During pregnancy, this medication should be used cautiously, as newborns may experience respiratory distress or withdrawal symptoms, especially during the late stages of pregnancy. In breastfeeding, this medication can be transferred through breast milk, so it is advisable to either stop breastfeeding or avoid administering the drug. This medication has numerous interactions with other drugs, particularly serotonergic agents, anticoagulants, and antipsychotic medications. Caution is required when driving or operating machinery, as individual differences exist. Special attention is needed for children or the elderly, with a recommended reduction in dosing for the elderly. This medication should be stored safely, out of reach of children.

Thrombocytopenia, anaphylactic reaction, inappropriate secretion of antidiuretic hormone, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, anxiety, agitation, abnormal dreams, decreased libido, sexual dysfunction, bruxism, restlessness, irritability, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, paresthesia, tremor, taste disorder, sleep disorder, syncope, serotonin syndrome, akathisia, movement disorders, convulsion, psychomotor agitation, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, orthostatic hypotension, sinusitis, yawning, epistaxis, nausea, diarrhea, constipation, vomiting, dry mouth, 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, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, tremor, dry mouth, polyuria, sedation, heartburn, anxiety, visual hallucinations, retrograde amnesia, seizure, mania, hyponatremia, bleeding, serotonin syndrome, withdrawal symptoms, dizziness, sleep disorder, anxiety, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual impairment, QT interval prolongation, sexual dysfunction

This medication should be stored in a light-protected, sealed container at room temperature between 1°C and 30°C. Maintaining this storage conditions will help preserve the medication's effectiveness and prevent deterioration.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle