Medication info
Seropram Tablet 10mg (Escitalopram Oxalate)

Seropram Tablet 10mg (Escitalopram Oxalate)

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

MFDS item code 201802618 · Approved 2018.06.22

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (including panic disorder), 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 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 needed for antidepressant effects to become apparent. Even after symptoms have resolved, at least 6 months of drug therapy is needed 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, then increase the dose 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 medication for more than 10 weeks for 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 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment of responding patients 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. Social anxiety disorder is a well-defined diagnostic term for a specific disorder and should not be confused with excessive shyness. Drug therapy should be given only when social anxiety disorder significantly interferes with occupational and social activities. Drug therapy has not been compared with cognitive behavioral therapy. Drug therapy is one part of an overall treatment strategy. (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 treatment 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 treatment 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, and treatment should be continued for a sufficient period to ensure symptom recovery. If this medication is administered long term, its usefulness and dose should be regularly reassessed for each patient. 2) Patients with renal impairment No dose 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 dose may be increased to 10mg per day. 4) Discontinuation 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 for the treatment of 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 for the treatment of 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. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, administration 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, 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 occurs first. Treatment with this medication may be restarted 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 injection of this medication 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 such use.

Ingredients

Manufacturer
Dasan Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (including panic 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 medicine is used to treat major depressive disorder, panic disorder (both with and 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 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 needed for antidepressant effects to become apparent. Even after symptoms have resolved, at least 6 months of drug therapy is needed 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, then increase the dose 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 medication for more than 10 weeks for 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 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment of responding patients 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. Social anxiety disorder is a well-defined diagnostic term for a specific disorder and should not be confused with excessive shyness. Drug therapy should be given only when social anxiety disorder significantly interferes with occupational and social activities. Drug therapy has not been compared with cognitive behavioral therapy. Drug therapy is one part of an overall treatment strategy. (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 treatment 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 treatment 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, and treatment should be continued for a sufficient period to ensure symptom recovery. If this medication is administered long term, its usefulness and dose should be regularly reassessed for each patient. 2) Patients with renal impairment No dose 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 dose may be increased to 10mg per day. 4) Discontinuation 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 for the treatment of 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 for the treatment of 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. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, administration 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, 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 occurs first. Treatment with this medication may be restarted 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 injection of this medication 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 such use.

Precautions

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or psychiatric conditions, so it should be used cautiously after consulting with a physician. This medication should not be taken in combination with certain drugs, particularly monoamine oxidase inhibitors (MAOIs), as this may lead to a dangerous serotonin syndrome. Patients with closed-angle glaucoma or a history of glaucoma should be cautious as this medication can dilate pupils and increase intraocular pressure. During the initial 1-2 weeks of treatment, side effects such as anxiety, insomnia, dizziness, and nausea may commonly occur, but most will decrease over time. This medication may affect blood clotting, so patients at risk of bleeding should be cautious and consult a physician if taking anticoagulants. Patients should be closely monitored for abnormal behavioral changes such as suicidal thoughts, aggression, and anxiety after starting treatment or changing doses, and family members or caregivers should also observe closely. Discontinuing this medication suddenly may result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, discontinuation should be done gradually according to a physician's directions. Patients with heart disease or at risk for QT prolongation should undergo electrocardiogram testing and be monitored closely, and any cases of hypokalemia or hypomagnesemia should be corrected beforehand. Pregnant women, especially in the later stages, should consult a physician before taking this medication as it can affect the newborn, and nursing mothers should discontinue breastfeeding or avoid taking this medication. Elderly patients are advised to start with a lower dose and increase cautiously. Caution is needed when driving or operating machinery, and if abnormal symptoms occur, care should be taken. This medication should ideally not be taken with alcohol, and since there is a risk of interactions with other drugs, patients must inform their physician or pharmacist of any other medications they are taking. In the event of an overdose, symptoms may include central nervous system symptoms, gastrointestinal symptoms, and cardiac arrhythmias, and immediate medical attention should be sought. Store this medication out of reach of children and avoid transferring it to another container to ensure safety.

Side effects

Thrombocytopenia, anaphylaxis, inappropriate secretion of antidiuretic hormone, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, anxiety, restlessness, abnormal dreams, decreased libido, sexual indifference, bruxism, agitation, irritability, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behaviors, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, syncope, serotonin syndrome, dyskinesia, movement disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval, polymorphic ventricular tachycardia, ventricular arrhythmias, 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 disorders, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, persistent erection, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fractures, palpitations, hypertension, paralysis, extrapyramidal disorders, migraine, chest pain, aggressive reactions, anorexia, hallucinations, drowsiness, insomnia, aggressive reactions, decreased libido, visual hallucinations, sedation, frequent urination, tremor, dry mouth, sweating, weight gain, anxiety, agitation, panic disorder, excitement, hostility, aggression, impulsivity, akathisia, hypomania, mania, dizziness, sensory disturbances, sleep disorders, agitation, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, suicidal tendencies, suicidal impulses, suicidal behaviors

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 protects it from light. Additionally, it is essential to store it at a temperature between 1 and 30 degrees Celsius 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.