Medication info

Ezipram Tablet 10mg (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injection
Ingredient · strength
Escitalopram Oxalate›12.77mg / 1 tablet
Manufacturer / importer
(Co., Ltd.) Huons
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603670 · Approved 2016.06.21

Summary

Main use
Treatment of major depressive disorder and anxiety disorders (panic disorder, social anxiety disorder, etc.), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
Safety has not been established for doses exceeding 20mg per day. This medication is administered once daily in the morning or evening, with or without food. 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 increasing the dose to 20mg, increase it at intervals of at least 1 week. In general, antidepressants take 2-4 weeks to take effect. Even after symptoms resolve, 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 once daily for 1 week, then increase to 10mg once daily. 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 medication for more 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 needed 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 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 reevaluated 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 administration 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 reevaluate the usefulness of long-term treatment with this medication 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 administration 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 treatment should continue for a sufficient period to ensure symptom remission. If this medication is administered long term, the usefulness and dose should be regularly 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 An initial dose of 5mg per day for the first 2 weeks is recommended. The dose may be increased to 10mg per day, depending on the patient's response. 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, at least 14 days must elapse after discontinuing this medication before starting an MAO inhibitor for the treatment of psychiatric disorders. 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 more urgent treatment for a psychiatric condition, including hospitalization and other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. If there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a specific patient, this medication 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 comes first. Treatment with this medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medication at 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
(Co., Ltd.) Huons

Efficacy & effects

Treatment of major depressive disorder and anxiety disorders (panic disorder, social anxiety disorder, etc.), 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 major depressive disorder, panic disorder (including cases with or without agoraphobia), social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder.

How it is given

Adult administration

Safety has not been established for doses exceeding 20mg per day. This medication is administered once daily in the morning or evening, with or without food. 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 increasing the dose to 20mg, increase it at intervals of at least 1 week. In general, antidepressants take 2-4 weeks to take effect. Even after symptoms resolve, 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 once daily for 1 week, then increase to 10mg once daily. 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 medication for more 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 needed 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 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 reevaluated 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 administration 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 reevaluate the usefulness of long-term treatment with this medication 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 administration 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 treatment should continue for a sufficient period to ensure symptom remission. If this medication is administered long term, the usefulness and dose should be regularly 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 An initial dose of 5mg per day for the first 2 weeks is recommended. The dose may be increased to 10mg per day, depending on the patient's response. 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, at least 14 days must elapse after discontinuing this medication before starting an MAO inhibitor for the treatment of psychiatric disorders. 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 more urgent treatment for a psychiatric condition, including hospitalization and other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. If there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a specific patient, this medication 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 comes first. Treatment with this medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medication at 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Precautions

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions, and should be used with caution. This medication contains escitalopram; it should not be taken if you are allergic to this ingredient or currently taking specific medications. In particular, concomitant use with MAO inhibitors or switching to them within a certain period is contraindicated due to risks. In patients with closed-angle glaucoma or a history of glaucoma, caution is warranted as this medication may dilate the pupils and increase intraocular pressure. During the initial 1-2 weeks of treatment, side effects such as anxiety, insomnia, dizziness, and nausea may frequently occur, but symptoms often lessen over time. Patients and caregivers should closely monitor for mental changes such as suicidal thoughts, aggression, and confusion during treatment. Furthermore, this medication may affect heart rate; therefore, patients with congenital long QT syndrome or those taking other drugs that prolong the QT interval may be at risk. Abrupt discontinuation of this medication may cause withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, thus it should be tapered gradually under a doctor's guidance. Women who are pregnant or nursing should consider the potential effects on the newborn and careful judgment is required; it is recommended to discontinue nursing during treatment. This medication may interact with other drugs, especially with serotonergic agents, anticoagulants, and certain antibiotics, thus caution is needed when used in combination. For elderly patients, it is advised to start with a lower initial dose and to increase it cautiously, and caution should also be exercised when driving or operating machinery. In case of overdose, symptoms may present in the central nervous system, cardiovascular system, and gastrointestinal system, necessitating immediate medical attention. This medication is not approved for use in children and adolescents, and its use should be avoided.

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, nervousness, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, altered perception, tremor, taste disturbance, sleep disorder, fainting, serotonin syndrome, movement disorder, motor impairment, convulsion, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval, polymorphic ventricular tachycardia, 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 disorder, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbance, cough, sexual dysfunction, palpitations, paralysis, extrapyramidal disorder, migraine, asthma, dyspnea, fracture, hypertension, chest pain, sleepiness, aggressive reaction, anorexia, visual hallucination, sedation, frequent urination, tremor, thirst, emotional instability, hyperreactivity, visual impairment, dizziness, sleep disorders, anxiety, tremor, confusion, sweating, diarrhea, palpitations, suicidal impulse, self-harm, hostility, unstable blood pressure, sweating, flushing, high fever, tics, myotonia, rash, chorea, seizures, hypotension, hypokalemia, hyponatremia

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

Storage

This medication is sensitive to light and should be stored in a container that blocks light. It is best to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the drug's efficacy for a long time.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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.