Medication info
ZepraMelts Oral Disintegrating Tablet 20 mg (Escitalopram Oxalate)

ZepraMelts Oral Disintegrating Tablet 20 mg (Escitalopram Oxalate)

Prescription medicationOrally disintegrating TabletOral · Intravenous injection
Ingredient · strength
Escitalopram Oxalate›25.54mg / 1 tablet
Manufacturer / importer
Jeil Pharmaceutical Co., Ltd.
Appearance
White round oral disintegrating tablet
Packaging
100 tablets/box [10 tablets/PTP x 10], 28 tablets/box [7 tablets/PTP x 4]
Approval status
Active

MFDS item code 202301593 · Approved 2023.05.17 · Insurance code 645406330

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (including panic disorder and social anxiety disorder), and obsessive-compulsive disorder
Who uses it
Adults
Adult dosage
The safety of doses exceeding 20mg per day has not been established. This medication is administered once daily, in the morning or evening, regardless of meals. This medication is an orally disintegrating tablet. Place it on the tongue and allow it to dissolve; it may be 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. Generally, 2-4 weeks are needed for antidepressants to take effect. Even after symptoms have resolved, drug therapy for at least 6 months is needed to ensure the treatment effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer an initial dose of 5mg once daily for 1 week, then increase to 10mg once daily. 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. 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 the treatment effect. Long-term treatment in responding patients was studied for 6 months, and should be considered individually 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 study was conducted in patients who responded to 12 weeks of open-label treatment, with 20mg per day administered 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 study was conducted in patients who responded to 16 weeks of open-label treatment, with 10mg or 20mg per day administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so the medication should be administered for a sufficient period to ensure recovery from symptoms. When this medication is administered long term, its usefulness and dose should be reassessed regularly 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 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 this medication because of the increased risk of serotonin syndrome. In patients requiring treatment for a more urgent 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 medication. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, 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 occurs 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 intravenous administration of this medication at 1mg/kg or less is unclear.

Ingredients

Manufacturer
Jeil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (including panic disorder and social anxiety disorder), and obsessive-compulsive disorder

  • Major depressive disorder
  • agoraphobia
  • panic disorder
  • social anxiety disorder
  • social phobia
  • generalized anxiety disorder
  • obsessive-compulsive disorder
View approved original text

This medication is used to treat various mental health issues, including major depressive disorder, panic disorder (with or without agoraphobia), social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder.

Dosage and Administration

Adult dosage

The safety of doses exceeding 20mg per day has not been established. This medication is administered once daily, in the morning or evening, regardless of meals. This medication is an orally disintegrating tablet. Place it on the tongue and allow it to dissolve; it may be 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. Generally, 2-4 weeks are needed for antidepressants to take effect. Even after symptoms have resolved, drug therapy for at least 6 months is needed to ensure the treatment effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer an initial dose of 5mg once daily for 1 week, then increase to 10mg once daily. 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. 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 the treatment effect. Long-term treatment in responding patients was studied for 6 months, and should be considered individually 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 study was conducted in patients who responded to 12 weeks of open-label treatment, with 20mg per day administered 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 study was conducted in patients who responded to 16 weeks of open-label treatment, with 10mg or 20mg per day administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so the medication should be administered for a sufficient period to ensure recovery from symptoms. When this medication is administered long term, its usefulness and dose should be reassessed regularly 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 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 this medication because of the increased risk of serotonin syndrome. In patients requiring treatment for a more urgent 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 medication. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, 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 occurs 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 intravenous administration of this medication at 1mg/kg or less is unclear.

Precautions

This medication is primarily used to treat psychiatric disorders associated with depression. Caution must be exercised when using this medication in children, adolescents, and young adults aged 18 to 24, as there may be an increased risk of suicidal thoughts or behaviors. Aspartame, an artificial sweetener included in this medication, should not be administered to patients with the genetic disorder phenylketonuria. Caution is advised when used in combination with certain medications, especially in patients taking MAO inhibitors, pimozide, or medications that can cause QT interval prolongation. Patients with glaucoma or a history of glaucoma should use this medication cautiously as it may affect the eyes. During the course of this medication, various adverse reactions such as anxiety, restlessness, insomnia, changes in appetite, weight changes, and decreased libido may occur, especially more frequently within the first 1-2 weeks of administration. If there are any mental changes such as suicidal thoughts or behaviors, aggression, or confusion, consult a doctor immediately. Abrupt discontinuation of this medication can lead to withdrawal symptoms including dizziness, anxiety, and sleep disturbances, and the dosage should be gradually reduced under a doctor's guidance. Patients with heart disease or suspected QT interval prolongation should undergo an electrocardiogram before using this medication and should periodically monitor their heart condition during use. If pregnant or breastfeeding, consult a doctor before taking this medication as it may affect the newborn, and it is advised to either avoid taking this medication or discontinue breastfeeding. Elderly patients are recommended to start at a lower dosage than that of general adults. Caution is required while driving or operating machinery, and one should closely observe their condition after taking this medication. In case of overdose, abnormal symptoms may appear affecting the central nervous system, gastrointestinal tract, and cardiovascular system, necessitating immediate medical care. Keep this medication out of reach of children, and avoid transferring it to another container to prevent accidents.

Side effects

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, neural excitability, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disturbances, syncope, serotonin syndrome, dyskinesia, movement disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, nosebleeds, nausea, diarrhea, constipation, dry mouth, abdominal pain, vomiting, 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, dyspepsia, enteritis, sensory disturbances, cough, sexual dysfunction, palpitations, paralysis, extrapyramidal symptoms, migraine, asthma, dyspnea, fractures, hypertension, chest pain, drowsiness, aggressive reactions, anorexia, hallucinations, dry mouth, tremors, abdominal discomfort, anxiety, insomnia, visual hallucinations, frequent urination, sedation, heartburn, withdrawal symptoms (dizziness, sleep disturbances, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual impairment)

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is also essential to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature to ensure the effectiveness and safety of the medication.

Appearance and packaging

Appearance

White round oral disintegrating tablet

Package unit

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

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.