Hanwha Escitalopram Tablet 10 mg (Escitalopram Oxalate)

Adult administration

The safety of doses exceeding 20mg per day has not been established. 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. 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, the increase should be made at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to appear. 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 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 chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in patients who respond 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 reassessed 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 reassess the usefulness of long-term treatment with this medication 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, administering 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so treatment should be continued for a sufficient period to ensure that symptoms have resolved. If this medication is used long term, its usefulness and dosage should be regularly reassessed 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 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 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 must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must 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 treatment with 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, treatment 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, 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 resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medication at a dose of 1mg/kg or less, is unclear.

This drug is an antidepressant used to treat psychiatric disorders such as major depression. There may be an increased risk of suicidal thoughts or behavior in children, adolescents, and young adults aged 18 to 24, thus caution must be exercised while using it. All patients taking this medication should be carefully monitored for changes in behavior such as worsening of the disease, suicidal tendencies, or aggression during the initial treatment or dose changes. Family members or guardians should carefully observe the patient’s condition and consult a doctor immediately if any abnormal signs appear. This medication should not be administered to patients with known allergies to specific ingredients or patients taking MAO inhibitors, as well as those with QT interval prolongation syndrome. Patients with closed-angle glaucoma or a history of glaucoma may require caution due to the mydriatic effect of this drug, which can lead to increased intraocular pressure. During the first 1-2 weeks of administration, various side effects such as anxiety, insomnia, dizziness, nausea, vomiting, weight changes, and decreased libido may occur, most of which decrease over time. This medication can cause a serious side effect known as serotonin syndrome, thus it should be used with caution when combined with serotonin-acting drugs, and treatment should be stopped immediately if symptoms occur. Abrupt discontinuation can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it should be reduced gradually under the guidance of a physician. During pregnancy, especially in the third trimester, it may affect the newborn, so pregnant women should consult their doctor thoroughly before administration, and breastfeeding women should avoid administration or stop breastfeeding. It is recommended to start at a reduced initial dose for elderly patients, and those with heart disease or electrolyte imbalances also require caution. When driving or operating machinery, individual differences may apply, but caution may be needed, so the patient's condition should be verified. In the case of overdose, central nervous system symptoms and cardiac arrhythmias may occur, requiring immediate medical attention, and there is no specific antidote. For storage, keep in a sealed container out of reach of children and avoid transferring to other containers.

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, tremors, taste abnormalities, sleep disorders, syncope, serotonin syndrome, movement disorders, motor dysfunction, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation on ECG, polymorphic ventricular tachycardia, orthostatic hypotension, sinusitis, yawning, nosebleed, nausea, diarrhea, constipation, vomiting, polydipsia, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, hair loss, rash, itching, purpura, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculatory dysfunction, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, paresthesia, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, hallucinations, asthma, dyspnea, fracture, arthralgia, hypertension, xerostomia, tremor, weight gain, abdominal discomfort, anxiety, insomnia, visual hallucinations, polyuria, sedation, heartburn, polydipsia, decreased libido, decreased appetite, increased sweating

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. Also, avoid storing the medication in excessively hot or cold places, keeping it at a normal room temperature between 1 and 30 degrees Celsius.

Appearance

White, rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle