Medication info

Citalopram Oxalate 10 mg (Escitalopram Oxalate)

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

MFDS item code 201901803 · Approved 2019.03.26

This product's status changed to Expired on 2024.03.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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, with or without food. (1) Major depressive disorder: The usual dosage 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 of this drug is to be increased to 20mg, the increase should be made at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to develop. Even after symptoms have resolved, at least 6 months of drug treatment is required to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer 5mg per day for 1 week as the initial dose, 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 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 dosage 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 it is recommended that treatment be continued for 12 weeks to ensure a therapeutic effect. Long-term treatment in patients who responded 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 periodically reassessed. 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 given only when social anxiety disorder significantly interferes with occupational and social activities. A comparison of drug treatment with cognitive behavioral therapy has not been evaluated. Drug treatment is one part of an overall treatment strategy. (4) Generalized anxiety disorder: The initial dosage 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 periodically reassess the usefulness of long-term treatment with this drug for each patient. (5) Obsessive-compulsive disorder: The usual dosage 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. Obsessive-compulsive disorder is a chronic condition, so this drug should be administered for a sufficient period to ensure recovery of symptoms. For long-term administration of this drug, the usefulness and dosage for each patient should be periodically reassessed. 2) Patients with renal impairment No dosage 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 that an initial dose of 5mg per day be administered 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 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 for the treatment of 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 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 drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug 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 patients already receiving this drug. 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 in a particular patient, this drug may be stopped 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 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 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
Seongwon Adcock 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, including major depressive disorder and panic disorder (with or without agoraphobia), social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder. These conditions help alleviate anxiety and depressive symptoms, proving effective in improving the patient's daily functioning. Therefore, this medication is used to promote mental stability and emotional health.

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, with or without food. (1) Major depressive disorder: The usual dosage 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 of this drug is to be increased to 20mg, the increase should be made at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to develop. Even after symptoms have resolved, at least 6 months of drug treatment is required to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer 5mg per day for 1 week as the initial dose, 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 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 dosage 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 it is recommended that treatment be continued for 12 weeks to ensure a therapeutic effect. Long-term treatment in patients who responded 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 periodically reassessed. 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 given only when social anxiety disorder significantly interferes with occupational and social activities. A comparison of drug treatment with cognitive behavioral therapy has not been evaluated. Drug treatment is one part of an overall treatment strategy. (4) Generalized anxiety disorder: The initial dosage 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 periodically reassess the usefulness of long-term treatment with this drug for each patient. (5) Obsessive-compulsive disorder: The usual dosage 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. Obsessive-compulsive disorder is a chronic condition, so this drug should be administered for a sufficient period to ensure recovery of symptoms. For long-term administration of this drug, the usefulness and dosage for each patient should be periodically reassessed. 2) Patients with renal impairment No dosage 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 that an initial dose of 5mg per day be administered 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 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 for the treatment of 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 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 drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug 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 patients already receiving this drug. 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 in a particular patient, this drug may be stopped 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 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 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 used for the treatment of psychiatric disorders such as major depression. It may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults aged 18 to 24, and careful evaluation and monitoring are required when prescribing to patients in this age group. This medication should not be administered to patients with hypersensitivity to the active ingredient or those taking specific drugs (e.g., MAO inhibitors, pimozide). Patients with closed-angle glaucoma or a history of glaucoma should be cautious as this medication may dilate the pupils and increase intraocular pressure. During the first 1-2 weeks of treatment, various side effects such as insomnia, anxiety, dizziness, and nausea may occur, but most symptoms tend to reduce over time. This medication can affect heart rhythm, causing QT interval prolongation; therefore, caution is needed for patients with heart disease or those taking related medications. While taking this medication, family members or caregivers should closely monitor for changes in mental state, such as suicidal tendencies, aggression, or anxiety, and inform a doctor immediately of any unusual signs. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, insomnia, or anxiety; therefore, the dosage should be gradually reduced according to a doctor's instructions. Women who are pregnant or breastfeeding should consult with a doctor, as this medication may affect a newborn; nursing mothers are advised to discontinue breastfeeding while taking this medication. It is advisable not to combine this medication with alcohol, and caution is needed when using it with other serotonin-acting drugs due to the risk of serotonin syndrome. Elderly patients should start with a reduced dosage, and caution may be required when driving or operating machinery. When storing this medication, keep it out of reach of children and do not transfer it to another container.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, hypersensitivity, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, syncope, serotonin syndrome, movement disorders, motor dysfunction, seizures, psychomotor agitation, inability to remain seated, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval, polymorphic ventricular tachycardia, orthostatic hypotension, sinusitis, yawning, nosebleed, nausea, diarrhea, constipation, vomiting, polydipsia, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, hair loss, rash, pruritus, petechiae, angioedema, arthralgia, 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, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, polyuria, tremor, dry mouth, sedation, heartburn, anxiety, visual hallucination, dizziness, anorexia

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

Storage

This medication is sensitive to light, so it should be stored in a special container that does not allow light in. Additionally, it is important to store it at room temperature, between 1°C and 30°C, to maintain its effectiveness.

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.