Zefram Melts Oral Disintegrating Tablet 10 mg (Escitalopram Oxalate)

Adult dosage

The safety of doses exceeding 20mg per day has not been established. This drug is administered once daily, in the morning or evening, regardless of meals. This drug is an orally disintegrating tablet. It may be placed on the tongue and allowed to dissolve, then taken with or without water. (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 drug 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 resolve, drug treatment for at least 6 months is required 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 this drug when administered for longer 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. In general, 2-4 weeks are required 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 it is recommended that treatment be continued for 12 weeks 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 periodically reevaluated. 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 component 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 periodically reevaluate the usefulness of long-term treatment with this drug 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, so treatment should be continued for a sufficient period to ensure symptom recovery. When this drug is used long term, its usefulness and dosage should be periodically reevaluated for each patient. 2) Patients with renal impairment No dose adjustment is necessary in 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 to administer an initial dose of 5mg per day for the first 2 weeks. Depending on the patient's response, the dose may be increased to 10mg per day. 4) Discontinuation of treatment When discontinuing this drug, 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 a psychiatric disorder and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment for a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. 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 drug may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after starting linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or with intravenous administration of this drug 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 primarily used to treat symptoms associated with depression. There may be an increased risk of suicidal thoughts or behavior, particularly in young adults aged 18 to 24, adolescents, and children during treatment with this medication; caution is advised. This medication contains aspartame, an artificial sweetener, which should not be taken by patients with phenylketonuria, a genetic disorder. This medication may be dangerous when taken with certain drugs, particularly monoamine oxidase inhibitors (MAOIs) or pimozide; they should not be used together. Patients with glaucoma or a history of glaucoma should also exercise caution when using this medication, as there is a possibility of increased intraocular pressure, and they should follow the doctor's directions. Various side effects may occur in the initial 1-2 weeks of use, such as anxiety, insomnia, dizziness, nausea, headache, and decreased libido, though symptoms often improve over time. This medication may cause cardiac-related side effects such as arrhythmia or QT interval prolongation, so patients with heart conditions or those currently taking related medications should be cautious. During the initial treatment period with antidepressants or when the dosage is changed, family members or caregivers should monitor for changes in mental state, such as suicidal thoughts, aggression, anxiety, or restlessness, and consult a doctor immediately if abnormal signs occur. Additionally, sudden discontinuation of the medication may lead to withdrawal symptoms such as dizziness, insomnia, anxiety, and nausea; therefore, it is essential to gradually reduce the dosage under the guidance of a physician. This medication should be used cautiously in pregnant women, especially during the later stages of pregnancy, and in nursing mothers; consultation with a physician is advised if needed. In elderly patients, it is recommended to start with a lower dose and adjust the maximum dose accordingly. Caution is necessary when driving or operating machinery as this medication may affect mental status. In case of overdose, symptoms related to the central nervous system, gastrointestinal system, and cardiovascular system may occur; immediately seek appropriate medical treatment at a healthcare facility. The safety and efficacy of this medication have not been adequately confirmed in children and adolescents; therefore, its use is not recommended. Finally, while taking this medication, there may be interactions with other drugs, so it is important to consult with a physician or pharmacist regarding all medications being taken.

Thrombocytopenia, anaphylactic reaction, 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, irritability, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, paresthesia, tremors, taste disturbances, sleep disorders, syncope, serotonin syndrome, movement disorders, motor disturbances, convulsions, psychomotor agitation, mydriasis, visual disturbances, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, orthostatic hypotension, sinusitis, yawning, nosebleed, 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 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, drowsiness, aggressive reaction, visual hallucinations, frequent urination, sedation, tremor, dry mouth, decreased appetite, sweating, weight gain, anxiety, agitation, panic disorder, insomnia, excitement, hostility, aggression, impulsivity, akathisia, hypomania, mania, dizziness, sensory disturbances, sleep disorders, insomnia, intense dreams, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations

Store this medication in a tightly closed container to protect it from air and moisture. It is advisable to maintain storage temperatures between 1°C and 30°C at room temperature.

Appearance

White round oral disintegrating tablet

Package unit

100 tablets/box [10 tablets/PTP x 10], 28 tablets/box [7 tablets/PTP x 4]