Medication info
Sarapram 15mg (Escitalopram Oxalate)

Sarapram 15mg (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injection
Ingredient · strength
Escitalopram Oxalate›19.155mg / 1 tablet
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202204261 · Approved 2022.11.28 · Insurance code 653006860

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 medication is administered once daily in the morning or evening, with or without food. 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, medication treatment for at least 6 months is needed to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: The recommended initial dose is 5mg per day for 1 week, followed by an 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 reevaluate 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 chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in responding patients has been studied for 6 months, and should be considered for each patient individually to prevent relapse. The usefulness of long-term treatment should be reevaluated regularly. (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 administration study was conducted in patients who responded to 12 weeks of open-label treatment, in which 20mg per day was administered for at least 6 months. The physician should regularly reevaluate 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 administration study was conducted in patients who responded to 16 weeks of open-label treatment, in which 10mg or 20mg per day was administered for at least 24 weeks. During long-term administration of this medication, the usefulness and dosage should be regularly reevaluated 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 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 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. 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 preparations should not start this medication because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue preparations to patients already receiving this medication. If no alternative to linezolid or intravenous methylene blue preparations is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue preparations are considered to outweigh the risk of serotonin syndrome, this medication may be stopped immediately and linezolid or intravenous methylene blue preparations may be administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or intravenous methylene blue preparations, 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 preparations. The risk associated with methylene blue preparations administered 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.

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 for the treatment of various anxiety and mood disorders including major depressive disorder, panic disorder (with or 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, with or without food. 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, medication treatment for at least 6 months is needed to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: The recommended initial dose is 5mg per day for 1 week, followed by an 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 reevaluate 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 chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in responding patients has been studied for 6 months, and should be considered for each patient individually to prevent relapse. The usefulness of long-term treatment should be reevaluated regularly. (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 administration study was conducted in patients who responded to 12 weeks of open-label treatment, in which 20mg per day was administered for at least 6 months. The physician should regularly reevaluate 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 administration study was conducted in patients who responded to 16 weeks of open-label treatment, in which 10mg or 20mg per day was administered for at least 24 weeks. During long-term administration of this medication, the usefulness and dosage should be regularly reevaluated 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 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 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. 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 preparations should not start this medication because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue preparations to patients already receiving this medication. If no alternative to linezolid or intravenous methylene blue preparations is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue preparations are considered to outweigh the risk of serotonin syndrome, this medication may be stopped immediately and linezolid or intravenous methylene blue preparations may be administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or intravenous methylene blue preparations, 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 preparations. The risk associated with methylene blue preparations administered 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.

Precautions

This medication is an antidepressant used in the treatment of psychiatric disorders such as major depression. This medication may increase the risk of suicidal thoughts or behaviors, especially when used in children, adolescents, and young adults aged 18 to 24. Therefore, healthcare providers must carefully assess the necessity and risks of administering this medication. During the use of this medication, watch closely for worsening depressive symptoms, suicidal ideation, and any abnormal behavioral changes such as aggression or anger, and families or caregivers should carefully observe the patient. It is advisable not to use this medication in children and adolescents as it is not approved for them. Patients with allergies to the components of this medication, or those taking certain drugs such as MAO inhibitors or pimozide, should not take this medication. Patients with a history of glaucoma or those with closed-angle glaucoma should use this medication with caution, as there is a risk of pupil dilation and increased intraocular pressure. Adverse reactions are most commonly observed during the first 1-2 weeks, and symptoms tend to decrease over time. Possible adverse effects during use include anxiety, insomnia, dizziness, nausea, weight changes, decreased libido, fatigue, etc. Caution is advised for patients with heart conditions or those at risk for QT interval prolongation due to potential heart arrhythmia. Sudden discontinuation of the medication may cause withdrawal symptoms such as dizziness, anxiety, sleep disturbances, so the dose should be gradually reduced in consultation with a physician. This medication can cause severe serotonin syndrome if taken with other serotonin agents, so it must be used very cautiously when combined with other medications. If pregnant or breastfeeding, consultation with a physician is essential because the use of this medication may have impacts on the fetus and newborn, and breastfeeding should be avoided or discontinued during treatment. For elderly patients, it is preferable to start with a lower initial dose and reduce the maximum dose as well. When driving or operating machinery, caution should be observed due to the potential effects of this medication on mental function. Overdose may result in symptoms related to the central nervous system, gastrointestinal system, and cardiovascular system, and immediate medical attention should be sought. Keep this medication out of reach of children, and transferring it to another container is not good for maintaining quality and 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, irritability, panic attacks, confusion, aggression, depersonalization, hallucination, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disturbances, fainting, serotonin syndrome, movement disorders, motor dysfunction, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation on ECG, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, nosebleeds, nausea, diarrhea, constipation, vomiting, dry mouth, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, hives, hair loss, rash, itching, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculatory dysfunction, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum bleeding, priapism, fatigue, fever, edema, headache, xerostomia, abdominal pain, indigestion, enteritis, sensory disturbances, cough, asthma, dyspnea, fractures, palpitations, hypertension, paralysis, extrapyramidal disorders, migraine, chest pain, drowsiness, aggressive reactions, hallucinations, sedation, frequent urination, tremors, dry mouth, heartburn, insomnia, emotional instability, hypersensitivity, visual impairment, withdrawal symptoms (dizziness, sleep disturbances, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations)

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 prevents light exposure. Additionally, it is advisable to store the medication at room temperature, meaning between 1 and 30 degrees Celsius, to maintain effectiveness for a longer period.

Appearance and packaging

Appearance

White oval 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.