Medication info
Sarapram 10mg (Escitalopram Oxalate)

Sarapram 10mg (Escitalopram Oxalate)

Prescription medicationTablet
Ingredient · strength
Escitalopram Oxalate›12.77mg / 1 tablet
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets, 100 tablets
Approval status
Active

MFDS item code 200811019 · Notified 2008.11.17 · Insurance code 653004430

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (such as panic disorder and social anxiety disorder), and obsessive-compulsive disorder
Who uses it
Adults
Adult dosage
Safety has not been established for doses exceeding 20mg per day. This medication is administered once daily in the morning or evening, without regard to 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 required for antidepressant effects to emerge. Even after symptoms have resolved, at least 6 months of pharmacological treatment 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, then 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 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 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 chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment of patients who responded to treatment was 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. Pharmacological treatment should be given 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. (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 trial 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 trial 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, so treatment should be continued for a sufficient period to ensure symptom recovery. When this medication is administered long term, the usefulness and dosage 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 is required 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 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 must 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 be started on this medication because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. 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 for a particular patient, this medication may be stopped immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after receiving linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this medication may be resumed 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 with intravenous administration 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 these uses.

Ingredients

Manufacturer
Korea Pharma Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (such as 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 distress, including major depressive disorder, panic disorder (with or without agoraphobia), social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder.

Dosage and Administration

Adult dosage

Safety has not been established for doses exceeding 20mg per day. This medication is administered once daily in the morning or evening, without regard to 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 required for antidepressant effects to emerge. Even after symptoms have resolved, at least 6 months of pharmacological treatment 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, then 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 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 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 chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment of patients who responded to treatment was 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. Pharmacological treatment should be given 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. (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 trial 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 trial 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, so treatment should be continued for a sufficient period to ensure symptom recovery. When this medication is administered long term, the usefulness and dosage 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 is required 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 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 must 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 be started on this medication because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. 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 for a particular patient, this medication may be stopped immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after receiving linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this medication may be resumed 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 with intravenous administration 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 these uses.

Precautions

This drug is an antidepressant used to treat psychiatric conditions such as major depression, and it should be used cautiously, especially in children, adolescents, and young adults aged 18 to 24 as it may increase the risk of suicidal thoughts and behaviors. This drug may pose risks when used in combination with certain medications, especially MAO inhibitors, pimozide, and drugs that prolong the QT interval should not be used together. Patients with closed-angle glaucoma or a history of glaucoma should be cautious as this medication can dilate the pupil and potentially increase intraocular pressure. During the initial 1-2 weeks of treatment, side effects such as anxiety, insomnia, nausea, and dizziness are common, and these symptoms often alleviate over time. Adverse effects have been reported that can affect various systems including blood, mental, nervous, cardiac, gastrointestinal, skin, and musculoskeletal; thus, if abnormal symptoms appear, the patient should immediately consult a healthcare professional. Both the patient and guardian should closely monitor for mental changes such as suicidal thoughts, aggression, hallucinations, or mania, and if such symptoms are observed, the physician should be notified immediately. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually decreased as directed by a physician. Patients with cardiac conditions or those at risk for QT interval prolongation should have their condition checked with an ECG before and during treatment with this medication. Pregnant or breastfeeding women should consult a doctor as the use of this medication may affect the fetus or newborn, and it is advisable to discontinue breastfeeding if using this drug. Elderly patients should start with a lower initial dose and also have a lower maximum dose set for safety. This medication may require caution when driving or operating machinery, so patients should carefully observe their condition and pay attention to safety. Overdose may lead to symptoms affecting the central nervous system, gastrointestinal tract, and cardiovascular system, and immediate emergency care and treatment from medical personnel are required. This medication is not recommended for children and adolescents as its safety and efficacy have not been established. While taking this medication, caution should be exercised regarding interactions with other serotonin agents or certain anticoagulants, and it is advisable to avoid concomitant use with alcohol.

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, nervousness, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, fainting, serotonin syndrome, movement disorders, dyskinesia, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval on ECG, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, epistaxis, nausea, diarrhea, constipation, vomiting, polydipsia, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, alopecia, 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, frequent urination, tremor, emotional instability, hyperreactivity, visual hallucination

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

Storage

This drug is sensitive to light and should be stored in a container that blocks light. Additionally, it should be kept at room temperature between 1°C and 30°C, avoiding extremely hot or cold places.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets, 100 tablets

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.