Medication info
Entalop 10 mg (Escitalopram Oxalate)

Entalop 10 mg (Escitalopram Oxalate)

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

MFDS item code 202000260 · Approved 2020.01.17 · Insurance code 055800190

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (including panic disorder and social anxiety disorder), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
The safety of doses exceeding 20mg per day has not been established. This medicine is administered once daily, in the morning or evening, with or without food. 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 of this medicine to 20mg, increase it at intervals of at least 1 week. In general, antidepressants take 2-4 weeks to take effect. After symptoms resolve, medication treatment for at least 6 months is needed to ensure the therapeutic effect. Panic disorder with or without agoraphobia: The recommended initial dose is 5mg once daily for 1 week, followed by an 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 occurs 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. 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure the 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. Social anxiety disorder is a well-defined diagnostic term for a specific disorder and should not be confused with excessive shyness. Pharmacological treatment should be used only when social anxiety disorder significantly interferes with occupational and social activities. Pharmacological treatment has not been compared with cognitive behavioral therapy. Pharmacological treatment is one part of an overall treatment strategy. 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 trial administering 20mg per day for at least 6 months was conducted in patients who responded to 12 weeks of open-label treatment. The physician should periodically reassess the usefulness of long-term treatment with this medicine for each patient. 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 treatment trial administering 10mg or 20mg per day for at least 24 weeks was conducted in patients who responded to 16 weeks of open-label treatment. Obsessive-compulsive disorder is a chronic condition, and treatment should be continued for a sufficient period to ensure symptom recovery. If this medicine is used long term, its usefulness and dose should be reassessed regularly for each patient. 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). 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. When discontinuing this medicine, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. When discontinuing an MAO inhibitor for the treatment of psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of psychiatric disorders. Treatment with this medicine should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. In patients requiring treatment for a more urgent 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 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 stopped 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 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 nonintravenous routes (oral tablets or local injection) or intravenous doses 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
Selbion 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 drug is used to treat major depressive disorder, panic disorder (including both cases with and without agoraphobia), social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder. It acts effectively on each symptom to alleviate the patient's anxiety and depression symptoms, thereby improving the quality of life.

How it is given

Adult administration

The safety of doses exceeding 20mg per day has not been established. This medicine is administered once daily, in the morning or evening, with or without food. 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 of this medicine to 20mg, increase it at intervals of at least 1 week. In general, antidepressants take 2-4 weeks to take effect. After symptoms resolve, medication treatment for at least 6 months is needed to ensure the therapeutic effect. Panic disorder with or without agoraphobia: The recommended initial dose is 5mg once daily for 1 week, followed by an 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 occurs 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. 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure the 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. Social anxiety disorder is a well-defined diagnostic term for a specific disorder and should not be confused with excessive shyness. Pharmacological treatment should be used only when social anxiety disorder significantly interferes with occupational and social activities. Pharmacological treatment has not been compared with cognitive behavioral therapy. Pharmacological treatment is one part of an overall treatment strategy. 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 trial administering 20mg per day for at least 6 months was conducted in patients who responded to 12 weeks of open-label treatment. The physician should periodically reassess the usefulness of long-term treatment with this medicine for each patient. 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 treatment trial administering 10mg or 20mg per day for at least 24 weeks was conducted in patients who responded to 16 weeks of open-label treatment. Obsessive-compulsive disorder is a chronic condition, and treatment should be continued for a sufficient period to ensure symptom recovery. If this medicine is used long term, its usefulness and dose should be reassessed regularly for each patient. 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). 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. When discontinuing this medicine, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. When discontinuing an MAO inhibitor for the treatment of psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of psychiatric disorders. Treatment with this medicine should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. In patients requiring treatment for a more urgent 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 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 stopped 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 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 nonintravenous routes (oral tablets or local injection) or intravenous doses 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 medication is an antidepressant that treats psychiatric disorders such as major depression. Caution is required when prescribing to children, adolescents, and young adults aged 18 to 24, as there may be an increased risk of suicidal thoughts and behaviors. This drug can be dangerous when taken with certain medications, so it should not be used with MAO inhibitors or pimozide. Patients with glaucoma or a history of glaucoma should be careful with this medication, as it can dilate the pupils and increase intraocular pressure. During the initial 1 to 2 weeks of treatment, common side effects such as dizziness, insomnia, nausea, and headaches may occur but will gradually decrease over time. Patients with heart disease or those at risk of prolonged QT intervals need to use this medication with caution due to the risk of cardiac arrhythmias. Behavioral changes such as worsening depression symptoms, suicidal thoughts, or aggression may occur at the beginning of antidepressant treatment or during dosage changes, so patients and caregivers should closely monitor the individual. Abrupt discontinuation of this medication can cause withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it should be tapered off gradually under a physician's guidance. Pregnant or breastfeeding women should discuss the use of this drug with a doctor, as it may affect the newborn. It is advisable not to take this medication with alcohol and caution is needed when driving or operating machinery. When storing this medication, keep it out of reach of children and do not transfer it to another container to ensure safety.

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, tremors, taste disorders, sleep disorders, fainting, serotonin syndrome, movement disorders, motor dysfunction, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation on ECG, 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 disorders, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory abnormalities, cough, sexual dysfunction, palpitations, paralysis, extrapyramidal disorders, migraine, asthma, dyspnea, fracture, hypertension, anxiety, restlessness, panic disorder, insomnia, excitement, hostility, aggression, impulsivity, akathisia, hypomania, mania, dizziness, sensory abnormalities, sleep disorders, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, headache, frequent urination, drowsiness, heartburn, sedation, thirst, decreased appetite, sweating, frequent urination, tremor, abdominal discomfort, anxiety, insomnia, visual hallucinations

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 and moisture, and it should be kept at a temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White, oblong 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.