Medication info

Citalopram 10 mg Tablets (Escitalopram Oxalate)

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

MFDS item code 201903399 · Approved 2019.05.24

This product's status changed to Expired on 2024.05.24. 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 (including panic and social anxiety disorders), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
The safety of doses exceeding 20mg per day has not been established. This medication should be 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, depending on the patient's response. 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, drug treatment for at least 6 months is required 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. The dose may be increased to a maximum of 20mg per day, depending on the patient's response. 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 needed for symptoms to improve. Thereafter, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day, depending on 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 patients who responded was studied for 6 months; it should be considered individually for each patient to prevent relapse. The usefulness of long-term treatment should be reassessed 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 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 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. The dose may be increased to a maximum of 20mg per day, depending on the patient's response. A long-term 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; this medication should be administered for a sufficient period to ensure recovery from symptoms. When this medication is administered long term, its usefulness and dosage should be regularly reassessed for each patient. 2) Patients with renal impairment No dosage 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. The dose may be increased to 10mg per day, depending on the patient's response. 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 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 observed. Conversely, if starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed since discontinuing this medication. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization or other interventional procedures, administration 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 in a particular patient, this medication 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 medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with methylene blue administered by non-intravenous routes (oral tablets or local injection) or with intravenous administration of this medication at doses of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Aprogen Biosciences, Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (including panic and social anxiety disorders), 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 major depressive disorder, panic disorder (both 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 should be 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, depending on the patient's response. 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, drug treatment for at least 6 months is required 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. The dose may be increased to a maximum of 20mg per day, depending on the patient's response. 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 needed for symptoms to improve. Thereafter, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day, depending on 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 patients who responded was studied for 6 months; it should be considered individually for each patient to prevent relapse. The usefulness of long-term treatment should be reassessed 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 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 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. The dose may be increased to a maximum of 20mg per day, depending on the patient's response. A long-term 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; this medication should be administered for a sufficient period to ensure recovery from symptoms. When this medication is administered long term, its usefulness and dosage should be regularly reassessed for each patient. 2) Patients with renal impairment No dosage 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. The dose may be increased to 10mg per day, depending on the patient's response. 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 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 observed. Conversely, if starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed since discontinuing this medication. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization or other interventional procedures, administration 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 in a particular patient, this medication 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 medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with methylene blue administered by non-intravenous routes (oral tablets or local injection) or with intravenous administration of this medication at doses of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Precautions

This drug may increase suicidal thoughts or behavior in younger individuals with major depression or psychiatric disorders, necessitating careful monitoring. Serious side effects may occur if this drug is combined with certain medications, therefore, patients taking MAO inhibitors or Pimozide should not use it. Patients with glaucoma or a history of glaucoma should use this medication cautiously as it may affect the eyes. During the first 1-2 weeks of treatment, side effects such as anxiety, insomnia, dizziness, and nausea may often occur, but symptoms may decrease over time. This drug can cause various adverse reactions such as changes in blood pressure, arrhythmias, bleeding tendencies, and hyponatremia; patients should consult a doctor immediately if symptoms occur. While taking this medication, changes in mental state such as suicidal thoughts, aggression, and anxiety may occur, so family or caregivers should closely monitor the patient. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; dosage should be gradually reduced according to a doctor's instructions. Patients with heart disease or symptoms of QT interval prolongation should have an electrocardiogram before taking this medication and periodically monitor cardiac condition during treatment. Women who are pregnant or breastfeeding should consult a healthcare provider before use due to potential effects on the fetus or newborn. It is advisable not to take this medication with alcohol, and caution is necessary when driving or operating machinery. The safety and efficacy of this drug have not been established in children or adolescents, thus its use is not recommended. Elderly patients should start with a lower initial dose and adjust the dosage cautiously.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, loss of appetite, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, nervousness, 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, akathisia, mydriasis, visual disturbances, tinnitus, tachycardia, bradycardia, prolonged QT interval, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, epistaxis, 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 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, paralysis, extrapyramidal disorders, migraine, hallucinations, asthma, shortness of breath, fractures, arthralgia, hypertension, xerostomia, tremors, weight gain, abdominal discomfort, anxiety, insomnia, visual distortions, retroactive anxiety, epileptic seizures, mania, changes in blood sugar control, anxiety, agitation, panic disorder, insomnia, excitement, hostility, aggression, impulsivity, akathisia, hyponatremia, petechiae, purpura, postpartum hemorrhage, serotonin syndrome, dizziness, sleep disorders, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, prolonged QT interval, polymorphic ventricular tachycardia, arrhythmia, hypokalemia, hyponatremia, nausea, constipation, xerostomia, abdominal pain, vomiting, dyspepsia, enteritis, diarrhea, headache, dizziness, sensory disturbances, paralysis, extrapyramidal disorders, migraine, drowsiness, insomnia, aggressive reactions, decreased libido, loss of appetite, hallucinations, cough, asthma, shortness of breath, weight gain, chest pain, fever, fractures, arthralgia, sexual dysfunction, palpitations, hypertension, nausea, headache, dizziness, drowsiness, gastrointestinal disorders, heartburn, sedation, thirst, decreased libido, decreased appetite, xerostomia, dyspepsia, sweating, frequent urination, sexual dysfunction, tremors, weight gain, abdominal discomfort, anxiety, insomnia, visual distortions, headache, frequent urination, dizziness, drowsiness, gastrointestinal disorders, heartburn, sedation, thirst, decreased libido, decreased appetite, xerostomia, dyspepsia, sweating, frequent urination, sexual dysfunction, tremors, weight gain, abdominal discomfort, anxiety, insomnia, visual distortions

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

Storage

This drug is sensitive to light, so it should be stored in a container that blocks light. Additionally, it should be stored at room temperature between 1 and 30 degrees Celsius, not in excessive heat or cold.

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.