Sarapram Tablet 5mg (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) Adults (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 of this medicine is to be increased to 20mg, the increase should be made at intervals of at least 1 week. In general, 2-4 weeks are required for antidepressant effects to appear. Even after symptoms have resolved, drug treatment for at least 6 months is required to ensure a treatment 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 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 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, 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 treatment effect. Long-term treatment in patients who respond has been studied for 6 months and should be considered for each 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 trial administering 20mg per day for at least 6 months was conducted in patients who responded to 12 weeks of open-label treatment. 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. The dose may be increased to a maximum of 20mg per day depending on the patient's response. A long-term treatment trial administering 10mg or 20mg per day for at least 24 weeks was conducted in patients who responded to 16 weeks of open-label treatment. Obsessive-compulsive disorder is a chronic condition, and treatment should be continued for a sufficient period to ensure that symptoms have recovered. If this medicine is administered long term, the usefulness and dose for each patient should be reassessed regularly. 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 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 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 for the treatment of 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 allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 14 days must have elapsed since 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 other interventional procedures, including hospitalization, or treatment for a more urgent psychiatric condition, 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, for a particular 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. 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 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 with intravenous administration of this medicine 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 is an antidepressant used to treat psychiatric disorders such as major depression. Its safety and efficacy have not been established in children and adolescents under the age of 18, so its use is not recommended. This medication may increase the risk of suicidal thoughts and behaviors; thus, care must be taken, especially when administering it to young adults aged 18 to 24. The patient's condition should be closely monitored, and family or caregivers should also observe for any changes in behavior. This medication should not be taken together with certain drugs. For example, co-administration with MAO inhibitors, pimozide, or drugs that prolong the QT interval may be dangerous. In patients with glaucoma or a history of glaucoma, care must be taken when administering this medication as it may dilate pupils and increase intraocular pressure. Common side effects such as anxiety, insomnia, dizziness, and nausea may appear during the initial 1 to 2 weeks of administration, but symptoms often subside over time. This medication may cause various side effects such as issues related to heart rhythm, blood abnormalities, neurological issues, digestive problems, skin rashes, sexual dysfunction, etc., so if any unusual symptoms occur, immediate consultation with a medical professional should be sought. In particular, since this medication may increase the risk of suicide, both patients and their families should closely observe for signs of suicidal thoughts, aggression, or impulsive behavior changes. Abrupt discontinuation of the medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it is essential to taper the dosage gradually under a doctor’s guidance. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and use should be avoided during breastfeeding or breastfeeding should be discontinued. Dosage adjustments are necessary for patients with decreased liver function or the elderly, and caution in use is advised for patients with heart disease. Caution is necessary when driving or operating machinery, as this medication may impair judgment. In case of overdose, serious symptoms such as dizziness, seizures, and heart arrhythmias may occur, so immediate emergency treatment is required. This medication should be kept out of the reach of children, and transferring it to other containers may adversely affect its quality, so care must be exercised.

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 attack, confusion, aggression, depersonalization, hallucination, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, syncope, serotonin syndrome, movement disorders, motility disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, nosebleed, 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, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, hallucination, asthma, dyspnea, fracture, arthralgia, hypertension, chest pain, sedation, tremor, dry mouth, polyuria, sexual dysfunction, emotional instability, hyperreactivity, visual impairment, dizziness, sleep disorders, anxiety, agitation, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, headache, polyuria, drowsiness, heartburn, thirst, decreased appetite, sweating, weight gain, abdominal discomfort, insomnia, visual hallucinations, aggressive reactions, decreased libido

This medication may be sensitive to light, so it should be kept in a container that does not allow light to enter. It is also recommended to store the medication at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent degradation.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle