Medication info
Sarapram 20mg (Escitalopram Oxalate) Tablet

Sarapram 20mg (Escitalopram Oxalate) Tablet

Prescription medicationTablet
Ingredient · strength
Escitalopram Oxalate›25.54mg / 1 tablet
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201400360 · Approved 2014.01.27 · Insurance code 653005320

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (including panic disorder and social anxiety disorder), and obsessive-compulsive disorder
Who uses it
Adults
Adult dosage
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. Adults 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, antidepressants take 2-4 weeks to produce an effect. Even after symptoms resolve, at least 6 months of drug therapy is required to ensure a therapeutic effect. Panic disorder with or without agoraphobia: It is recommended to start with 5mg per day for 1 week and 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 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 whether continued treatment is needed. Social anxiety disorder: The usual dose is 10mg once daily. Generally, 2-4 weeks are needed to improve symptoms. 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 respond has been studied for 6 months and should be considered individually for each patient to prevent relapse. The benefits of long-term treatment should be reassessed periodically. 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, administering 20mg per day for at least 6 months. The physician should periodically reassess the benefits of long-term treatment with this medication for each patient. 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, administering 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition; treatment should continue for a sufficient period to ensure symptom resolution. For long-term treatment with this medication, the benefits for each patient and the dose should be reassessed periodically. 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). 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. Discontinuation of treatment When discontinuing this medication, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. 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 must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medication. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with 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, treatment 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, 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 methylene blue administered by nonintravenous routes (oral tablets or local injection) or with intravenous administration of this medication at a dose of 1mg/kg or less is unclear.

Ingredients

Manufacturer
Korea Pharma 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 medication is used to treat various mental health issues, including panic disorder and agoraphobia associated with major depressive disorder, social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder. It effectively alleviates anxiety symptoms and feelings of depression, helping improve patients' daily lives.

Dosage and Administration

Adult dosage

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. Adults 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, antidepressants take 2-4 weeks to produce an effect. Even after symptoms resolve, at least 6 months of drug therapy is required to ensure a therapeutic effect. Panic disorder with or without agoraphobia: It is recommended to start with 5mg per day for 1 week and 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 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 whether continued treatment is needed. Social anxiety disorder: The usual dose is 10mg once daily. Generally, 2-4 weeks are needed to improve symptoms. 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 respond has been studied for 6 months and should be considered individually for each patient to prevent relapse. The benefits of long-term treatment should be reassessed periodically. 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, administering 20mg per day for at least 6 months. The physician should periodically reassess the benefits of long-term treatment with this medication for each patient. 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, administering 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition; treatment should continue for a sufficient period to ensure symptom resolution. For long-term treatment with this medication, the benefits for each patient and the dose should be reassessed periodically. 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). 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. Discontinuation of treatment When discontinuing this medication, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. 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 must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medication. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with 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, treatment 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, 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 methylene blue administered by nonintravenous routes (oral tablets or local injection) or with intravenous administration of this medication at a dose of 1mg/kg or less is unclear.

Precautions

This drug is primarily used as an antidepressant to treat psychiatric disorders related to depression. There may be an increased risk of suicidal thoughts or behavior when administered to children, adolescents, or young adults, and physicians should carefully evaluate the necessity and risks of treatment. This medication can be dangerous when used in combination with certain drugs. Patients already taking MAO inhibitors or pimozide, or drugs that prolong the QT interval, should not take this medication. Additionally, patients with issues digesting lactose should also avoid it. Patients with glaucoma or a history of glaucoma should take caution as this medication may dilate pupils and increase intraocular pressure. During the course of treatment, side effects such as anxiety, insomnia, dizziness, nausea, weight change, and decreased libido may occur, while serious mental changes or cardiac arrhythmias may rarely occur. If such symptoms arise, it is important to contact a physician immediately. During the initiation of treatment or dose adjustments, careful observation for worsening depressive symptoms or behavioral changes such as suicidal tendencies and aggression is required, and family members or caregivers should monitor the patient closely. Suddenly discontinuing this medication may cause withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage must be tapered gradually under a physician's guidance. This medication can affect the heart, so patients with heart disease or prolonged QT interval should undergo an EKG before taking. Pregnant or breastfeeding women should consult with their physician when using this medication as it might impact the newborn. Specifically, while breastfeeding, this medication can be excreted in breast milk, potentially requiring cessation of breastfeeding. It is recommended to avoid taking this medication with alcohol, and caution is advised when driving or operating machinery. In cases of overdose, symptoms such as dizziness, tremors, nausea, and heart irregularities may occur, necessitating immediate emergency treatment if suspected. This medication is not recommended for children and adolescents as its safety and efficacy have not been established, and elderly patients should start with a lower initial dose. During treatment, potential interactions with other medications must be communicated to and monitored by the physician or pharmacist.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate secretion of antidiuretic hormone, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, appetite loss, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, nervousness, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disturbances, syncope, serotonin syndrome, movement disorders, dyskinesia, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation, polymorphic ventricular tachycardia, ventricular arrhythmia, 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 disorder, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory abnormalities, cough, sexual dysfunction, palpitations, paralysis, extrapyramidal disorder, migraine, asthma, dyspnea, fracture, hypertension

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

Storage

This medication is sensitive to light; therefore, it should be stored in a tightly sealed container that blocks light. It is also important to keep it at a temperature between 1 and 30 degrees Celsius for safe use.

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.