Zefram Melts Oral Disintegrating Tablets 5 mg (Escitalopram Oxalate)

Adult dosage

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. This medicine is an orally disintegrating tablet. It may be placed on the tongue and allowed to dissolve, then taken with or without water. 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 the dose is to be increased to 20mg, it should be increased 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 required to ensure a lasting 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 the dose 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. Generally, 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 of responding patients 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. (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, so treatment should be continued for a sufficient period to ensure symptom recovery. With long-term administration of this medicine, the usefulness and dose 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 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 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 observed. Conversely, when starting an MAO inhibitor for the treatment of 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 this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment for a psychiatric condition, including hospitalization, other interventions 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. 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 risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear.

This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with Major Depression or psychiatric disorders, so it should be used with caution. This drug contains aspartame, which is metabolized to phenylalanine, so it should not be taken by patients with phenylketonuria. It is not to be administered to patients with hypersensitivity to this drug or those taking MAO inhibitors, pimozide, or drugs that prolong the QT interval. Patients with closed-angle glaucoma or a history of glaucoma should use this drug with caution as it may cause pupil dilation and increase the risk of elevated intraocular pressure. During the initial 1-2 weeks of administration, side effects such as anxiety, insomnia, dizziness, and nausea may commonly occur but tend to decrease over time. This drug may provoke psychiatric side effects such as suicidal tendencies, aggression, and hallucinations; therefore, both the patient and caregiver should closely monitor any changes in symptoms. This drug may increase the risk of seizures, requiring cautious administration in patients with epilepsy, and it should be discontinued immediately if seizures occur. It may affect blood glucose control, so diabetic patients should closely monitor changes in blood glucose. Abrupt withdrawal from this drug may cause withdrawal symptoms like dizziness, anxiety, and sleep disturbances, so it should be gradually reduced in consultation with a physician. This drug could prolong the QT interval and increase the risk of cardiac arrhythmias, so an ECG may be necessary before and after administration in patients with heart disease. This drug can cause sexual dysfunction and the symptoms may persist, so patients should consult a physician if such symptoms arise. When used in conjunction with other serotonergic drugs, a serious side effect known as serotonin syndrome may occur, hence caution is required when combining medications. During pregnancy, especially in the later stages, it may affect the newborn, and pregnant women must consult a physician before use; nursing mothers should avoid use or discontinue breastfeeding. For elderly patients, it is safer to start at a lower dose, and use in children and adolescents is not recommended. Caution is needed when driving or operating machinery as symptom changes may occur during administration. In the case of overdose, central nervous system, cardiovascular, and gastrointestinal symptoms may appear, and immediate contact with a medical institution is required for appropriate treatment. This drug should be kept out of the reach of children, and it is safer not to transfer it into other containers.

Thrombocytopenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, anxiety, agitation, abnormal dreams, decreased libido, sexual dysfunction, bruxism, restlessness, nervous hyperactivity, panic attack, confusion, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, 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, 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, gastroenteritis, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine

This drug should be stored in a tightly sealed container to prevent exposure to air, ideally at a temperature between 1 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication is maintained for a longer time and it can be used safely.

Appearance

White round oral disintegrating tablet

Package unit

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