Medication info

Escitalopram Oxalate Tablet 10mg

Prescription medicationTabletIntravenous injectionExpired
Ingredient · strength
Escitalopram Oxalate›12.77mg / 1 tablet
Manufacturer / importer
Korea Pavis Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201902178 · Approved 2019.04.10

This product's status changed to Expired on 2024.04.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (including panic and social anxiety disorders), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
Safety has not been established for doses exceeding 20mg per day. This drug 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, it should be increased at intervals of at least 1 week. In general, 2-4 weeks are required for antidepressant effects to become apparent. 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, followed by an 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 drug 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 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in responding patients has been 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, administering 20mg per day for at least 6 months. The physician should regularly reassess 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 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 recovery from symptoms. When this drug is administered long term, its usefulness and dosage should be reassessed regularly for each patient. 2) Patients with renal impairment No dosage 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 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 for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 14 days should 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 this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventions, administration 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug 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 drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection) or intravenous administration of this drug at a dose of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Korea Pavis Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (including panic and social anxiety disorders), 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 a variety of anxiety and depression-related disorders, including major depressive disorder, panic disorder, 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 drug 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, it should be increased at intervals of at least 1 week. In general, 2-4 weeks are required for antidepressant effects to become apparent. 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, followed by an 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 drug 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 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in responding patients has been 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, administering 20mg per day for at least 6 months. The physician should regularly reassess 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 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 recovery from symptoms. When this drug is administered long term, its usefulness and dosage should be reassessed regularly for each patient. 2) Patients with renal impairment No dosage 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 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 for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 14 days should 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 this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventions, administration 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug 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 drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection) or intravenous administration of this drug at a dose of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Precautions

This drug is an antidepressant used to treat psychiatric disorders such as major depression. Particularly in young patients aged 18 to 24 years, there may be an increased risk of suicidal thoughts or behavior, so caution is required when administering this drug to patients in this age group. This drug should not be used in conjunction with certain medications, particularly MAO inhibitors, as combined or sequential administration can lead to a serious side effect known as serotonin syndrome. Additionally, patients with hypersensitivity to this drug, certain heart conditions, or metabolic disorders such as lactose intolerance should not be treated with this drug. Patients with glaucoma or a history of glaucoma should be cautious as this medication may increase intraocular pressure. Common side effects may occur during the initial dosing period, such as anxiety, insomnia, headache, and nausea, but these symptoms tend to diminish over time. This medication may affect blood coagulation, so patients at risk of bleeding or those taking medications that affect blood coagulation should be cautious. Sudden discontinuation of this medication may trigger withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so do not discontinue abruptly without medical advice and gradually reduce the dosage. Women who are pregnant or breastfeeding should carefully consider its use as it may affect the newborn; cessation of breastfeeding is recommended while taking this medication. Elderly patients should start at a lower dose than adults and increase it cautiously, as they may need to be extra careful when driving or operating machinery. This medication may interact with several other drugs, therefore it is essential to consult with healthcare professionals if taking other medications.

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, irritability, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremor, taste disturbance, sleep disorder, syncope, serotonin syndrome, movement disorders, motor dysfunction, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, nosebleed, nausea, diarrhea, constipation, vomiting, thirst, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, alopecia, rash, itching, petechiae, 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, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorders, migraine, chest pain, frequency of urination, tremors, dry mouth, sedation, heartburn, anxiety, visual hallucinations, dizziness, emotional instability, hyperreactivity, visual impairment, withdrawal symptoms, hypokalemia, hypomagnesemia, hypotension, coma

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

Storage

This medication is sensitive to light, so it should be stored in a light-protected, tightly closed container. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain its efficacy.

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.