Medication info
Seroca tablet 5mg (Escitalopram Oxalate)

Seroca tablet 5mg (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injection
Ingredient · strength
Escitalopram Oxalate›6.39mg / 1 tablet
Manufacturer / importer
Samjin Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201801444 · Approved 2018.03.30 · Insurance code 647804660

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (e.g., panic disorder and social anxiety disorder), 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, regardless of meals. 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 according to the patient's response. If the dose of this drug 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 evident. Even after symptoms have resolved, 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 per day for 1 week, then increase to 10mg per day. The dose may be increased to a maximum of 20mg per day according to the patient's response. 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 needed for symptoms to improve. Thereafter, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day according to the patient's response. 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; it 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 treatment should be used only when social anxiety disorder significantly interferes with occupational and social activities. Drug treatment has not been compared with cognitive behavioral therapy. Drug treatment is one part of an overall treatment strategy. (4) Generalized anxiety disorder: The initial dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response, after treatment for at least 1 week. A long-term treatment trial 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. The dose may be increased to a maximum of 20mg per day according to the patient's response. A long-term treatment trial 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 continue for a sufficient period to ensure symptom recovery. When this drug is used long term, its usefulness and dose should be regularly reassessed 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 It is recommended to administer an initial dose of 5mg per day for the first 2 weeks. The dose may be increased to 10mg per day according to the patient's response. 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 used to treat 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, if starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must 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 treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring other interventional procedures, including hospitalization, or treatment of a more urgent psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. 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 in a particular patient, this drug may be discontinued 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 drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection) or with intravenous administration of this drug at 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
Samjin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (e.g., 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 medication is used to treat various mental health conditions such as major depressive disorder, panic disorder (whether or not agoraphobia is present), social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder. It helps to alleviate anxiety and depressive symptoms and improves difficulties in daily life. This medication plays a positive role in managing symptoms when daily life is restricted due to these symptoms.

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, regardless of meals. 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 according to the patient's response. If the dose of this drug 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 evident. Even after symptoms have resolved, 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 per day for 1 week, then increase to 10mg per day. The dose may be increased to a maximum of 20mg per day according to the patient's response. 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 needed for symptoms to improve. Thereafter, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day according to the patient's response. 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; it 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 treatment should be used only when social anxiety disorder significantly interferes with occupational and social activities. Drug treatment has not been compared with cognitive behavioral therapy. Drug treatment is one part of an overall treatment strategy. (4) Generalized anxiety disorder: The initial dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient's response, after treatment for at least 1 week. A long-term treatment trial 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. The dose may be increased to a maximum of 20mg per day according to the patient's response. A long-term treatment trial 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 continue for a sufficient period to ensure symptom recovery. When this drug is used long term, its usefulness and dose should be regularly reassessed 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 It is recommended to administer an initial dose of 5mg per day for the first 2 weeks. The dose may be increased to 10mg per day according to the patient's response. 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 used to treat 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, if starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must 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 treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring other interventional procedures, including hospitalization, or treatment of a more urgent psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. 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 in a particular patient, this drug may be discontinued 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 drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection) or with intravenous administration of this drug at 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 primarily used to treat symptoms associated with depression. During treatment with this medication, especially in young patients aged 18 to 24, there is an increased risk of suicidal thoughts or behavior. Therefore, doctors and family members should closely monitor the patient's condition. This medication may be dangerous when taken with certain drugs, so it is essential to inform the doctor if other medications are being taken. In particular, it should not be taken with MAO inhibitors or pimozide, or with medications that prolong the QT interval. Patients with a history of glaucoma should be cautious as this medication can dilate the pupils and increase intraocular pressure. During the initial 1 to 2 weeks of treatment, various side effects such as anxiety, insomnia, dizziness, and nausea may occur, but these symptoms often decrease over time. This medication can affect several bodily systems, including cardiac arrhythmias, hypotension, blood abnormalities, liver dysfunction, and bleeding tendencies, so the patient should consult a doctor immediately if any abnormal symptoms occur. Abruptly stopping this medication can result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be reduced gradually under a doctor's guidance. Pregnant or breastfeeding women should discuss with their doctor the potential effects of this medication on the fetus or newborn, and breastfeeding should be avoided or the medication should be refrained from during breastfeeding. Elderly patients may be more sensitive to the effects of the medication, so it is advisable to start with a lower dosage. Caution should be taken while driving or operating machinery as this medication may affect mental functions. Overdosing on this medication can lead to severe central nervous system symptoms or cardiac issues, so strict adherence to the doctor's instructions is essential. When storing, keep it out of the reach of children and do not transfer it to other containers for safety.

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, hyperactivity, panic attack, confusion, aggression, depersonalization, hallucinations, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disturbances, sleep disorders, syncope, serotonin syndrome, movement disorders, motor dysfunction, seizures, psychomotor agitation, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval on electrocardiogram, polymorphic ventricular tachycardia, orthostatic hypotension, sinusitis, yawning, nosebleeds, nausea, diarrhea, constipation, vomiting, thirst, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, hair loss, rash, itching, petechiae, angioedema, joint pain, myalgia, rhabdomyolysis, urinary retention, ejaculation disorders, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, shortness of breath, fractures, palpitations, hypertension, somnolence, aggressive reactions, chest pain, sedation, polyuria, tremors, abdominal discomfort, anxiety, visual illusions, paralysis, extrapyramidal disorders, migraine, sexual dysfunction, decreased libido, anorexia

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It's important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the effectiveness and safety of the medication for a long time.

Appearance and packaging

Appearance

White round 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.