Medication info

Escitalopram Oxalate Tablets 20 mg

Prescription medicationTabletIntravenous injectionExpired
Ingredient · strength
Escitalopram Oxalate›25.54mg / 1 tablet
Manufacturer / importer
HanKook Pavis Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201902176 · 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 (panic, social anxiety, and generalized anxiety disorders), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
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. 1) Adults (1) Major depressive disorder: The usual dosage is 10mg once daily. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day. If increasing the dosage of this medication to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are required for the effects of antidepressants to become apparent. Even after symptoms have resolved, 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 5mg per day as the initial dosage for 1 week, and then increase to 10mg per day. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day. The maximum effect is seen 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 dosage is 10mg once daily. In general, 2-4 weeks are required for symptoms to improve. Thereafter, depending on the patient's response, the dosage 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 of patients who responded 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 reassessed regularly. (4) Generalized anxiety disorder: The initial dosage is 10mg once daily. Depending on the patient's response, the dosage 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 reassess the usefulness of long-term treatment with this medication for each patient. (5) Obsessive-compulsive disorder: The usual dosage is 10mg once daily. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day. 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; this medication should be administered for a sufficient period to ensure recovery from symptoms. For long-term administration of this medication, the usefulness and dosage for each patient should be reassessed regularly. 2) Patients with renal impairment No dosage adjustment is necessary for 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 dosage may be increased to 10mg per day. 4) Discontinuation of treatment When discontinuing this medication, the dosage 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 should 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 preparations should not start this medication because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, administration should be considered. It may be necessary to urgently administer linezolid or an intravenous methylene blue preparation to a patient already receiving this medication. If there is no alternative to linezolid or an intravenous methylene blue preparation and the benefits of treatment with linezolid or an intravenous methylene blue preparation are judged to outweigh the risk of serotonin syndrome in a particular patient, this medication may be discontinued immediately and linezolid or an intravenous methylene blue preparation administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or an intravenous methylene blue preparation, or until 24 hours after the last dose, whichever occurs first. Treatment with this medication may be restarted 24 hours after the last dose of linezolid or an intravenous methylene blue preparation. The risk associated with administration of methylene blue preparations by non-intravenous routes (oral tablets or local injection) or intravenous administration of this medication at doses of 1mg/kg or less is unclear.

Ingredients

Manufacturer
HanKook Pavis Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (panic, social anxiety, and generalized 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 for the treatment of 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

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. 1) Adults (1) Major depressive disorder: The usual dosage is 10mg once daily. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day. If increasing the dosage of this medication to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are required for the effects of antidepressants to become apparent. Even after symptoms have resolved, 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 5mg per day as the initial dosage for 1 week, and then increase to 10mg per day. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day. The maximum effect is seen 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 dosage is 10mg once daily. In general, 2-4 weeks are required for symptoms to improve. Thereafter, depending on the patient's response, the dosage 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 of patients who responded 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 reassessed regularly. (4) Generalized anxiety disorder: The initial dosage is 10mg once daily. Depending on the patient's response, the dosage 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 reassess the usefulness of long-term treatment with this medication for each patient. (5) Obsessive-compulsive disorder: The usual dosage is 10mg once daily. Depending on the patient's response, the dosage may be increased to a maximum of 20mg per day. 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; this medication should be administered for a sufficient period to ensure recovery from symptoms. For long-term administration of this medication, the usefulness and dosage for each patient should be reassessed regularly. 2) Patients with renal impairment No dosage adjustment is necessary for 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 dosage may be increased to 10mg per day. 4) Discontinuation of treatment When discontinuing this medication, the dosage 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 should 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 preparations should not start this medication because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, administration should be considered. It may be necessary to urgently administer linezolid or an intravenous methylene blue preparation to a patient already receiving this medication. If there is no alternative to linezolid or an intravenous methylene blue preparation and the benefits of treatment with linezolid or an intravenous methylene blue preparation are judged to outweigh the risk of serotonin syndrome in a particular patient, this medication may be discontinued immediately and linezolid or an intravenous methylene blue preparation administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or an intravenous methylene blue preparation, or until 24 hours after the last dose, whichever occurs first. Treatment with this medication may be restarted 24 hours after the last dose of linezolid or an intravenous methylene blue preparation. The risk associated with administration of methylene blue preparations by non-intravenous routes (oral tablets or local injection) or intravenous administration of this medication at doses of 1mg/kg or less is unclear.

Precautions

This medication is an antidepressant used in the treatment of major depression and other psychiatric disorders. Caution should be exercised when using in children, adolescents, and young adults (aged 18-24), as there may be an increased risk of suicidal thoughts and behavior. It should not be used in combination with MAO inhibitors, pimozide, or drugs that prolong the QT interval due to safety concerns. Patients with narrow-angle glaucoma should be cautious, as this medication may dilate the pupils and increase intraocular pressure. Side effects such as anxiety, restlessness, insomnia, and nausea commonly occur during the first 1-2 weeks of treatment and tend to decrease over time. This medication may cause serious side effects such as serotonin syndrome, hyponatremia, bleeding tendency, cardiac arrhythmias, and sexual dysfunction; therefore, immediate consultation with a healthcare provider is necessary if these symptoms arise. When discontinuing this medication, dosage should be tapered gradually to avoid withdrawal symptoms like dizziness, anxiety, and sleep disturbances. Pregnant women should use this medication under the guidance of a physician due to potential effects on the fetus and newborn; breastfeeding mothers should stop nursing or avoid medication use. It is advisable for elderly patients to start at half the usual dose, and diabetic patients should monitor blood sugar levels carefully. Caution is advised when driving or operating machinery, and patients should assess their symptoms when doing so. If changes in mental state, suicidal tendencies, or aggression occur during treatment, healthcare providers should be informed immediately. Additionally, the risk of serotonin syndrome may increase when used with other serotonergic agents, so caution is warranted.

Side effects

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, perceptual disturbances, tremor, taste disorders, sleep disturbances, syncope, serotonin syndrome, dyskinesia, movement disorders, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation on ECG, polymorphic ventricular tachycardia, ventricular arrhythmia, 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 disorder, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, urinary frequency, sedation, tremor, dry mouth, abdominal discomfort, anxiety, insomnia, visual hallucinations, retrograde anxiety, epileptic seizure, mania, changes in blood sugar control, suicidal impulses, changes in abnormal behavior, agitation, excitement, hostility, aggressiveness, impulsivity, akathisia, euphoria, withdrawal symptoms, dizziness, sleep disturbances, anxiety, tremor, confusion, sweating, diarrhea, emotional instability, hypersensitivity, visual impairment, QT interval prolongation, persistent sexual dysfunction

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 does not allow light in. It is also important to maintain the storage temperature between 1 to 30 degrees Celsius to preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

White oval film-coated tablets

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.