Medication info
Nexalon Tablet 10 mg (Escitalopram Oxalate)

Nexalon Tablet 10 mg (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injection
Ingredient · strength
Escitalopram Oxalate›12.77mg / 1 tablet
Manufacturer / importer
Dongkuk Pharmaceutical Co., Ltd.
Appearance
White, rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201802641 · Approved 2018.06.26 · Insurance code 653404060

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 medicine 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 increasing the dose of this medicine to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are required for antidepressant effects to become apparent. Even after symptoms have resolved, drug therapy for at least 6 months 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 medicine 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 has been studied for 6 months, and 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, in which 20mg per day was administered for at least 6 months. The physician should regularly reassess the usefulness of long-term treatment with this medicine 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 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 medicine should be administered for a sufficient period to ensure symptom recovery. When this medicine is administered long term, the benefit for each patient and the dose should be reassessed regularly. 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 medicine, 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 medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue preparations should not start this medicine because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue preparations to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue preparations is available, and the benefits of treatment with linezolid or intravenous methylene blue preparations are judged to outweigh the risk of serotonin syndrome in a particular patient, this medicine may be discontinued immediately and linezolid or intravenous methylene blue preparations 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 medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue preparations. The risk associated with administration of methylene blue preparations by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear.

Ingredients

Manufacturer
Dongkuk Pharmaceutical 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 medicine is used for the treatment of 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 medicine 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 increasing the dose of this medicine to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are required for antidepressant effects to become apparent. Even after symptoms have resolved, drug therapy for at least 6 months 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 medicine 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 has been studied for 6 months, and 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, in which 20mg per day was administered for at least 6 months. The physician should regularly reassess the usefulness of long-term treatment with this medicine 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 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 medicine should be administered for a sufficient period to ensure symptom recovery. When this medicine is administered long term, the benefit for each patient and the dose should be reassessed regularly. 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 medicine, 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 medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue preparations should not start this medicine because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue preparations to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue preparations is available, and the benefits of treatment with linezolid or intravenous methylene blue preparations are judged to outweigh the risk of serotonin syndrome in a particular patient, this medicine may be discontinued immediately and linezolid or intravenous methylene blue preparations 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 medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue preparations. The risk associated with administration of methylene blue preparations by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear.

Precautions

This drug is an antidepressant used to treat psychiatric disorders such as major depression. During the use of this medication, there is an increased risk of suicidal thoughts or behaviors, particularly in young patients aged 18 to 24, so the doctor should carefully assess the necessity and risks of treatment. This drug should not be taken with certain medications, especially MAO inhibitors, pimozide, and drugs that prolong the QT interval. Patients with glaucoma or a history of glaucoma should be cautious as the side effect of pupil dilation may cause an increase in intraocular pressure. Common side effects such as anxiety, insomnia, dizziness, nausea, and headache may occur in the first 1 to 2 weeks of taking this medication, but symptoms often reduce over time. Additionally, serious side effects such as thrombocytopenia, liver dysfunction, cardiac arrhythmias, and serotonin syndrome may occur rarely. In case of abnormal symptoms, one should consult a doctor immediately. If this drug is suddenly stopped, withdrawal symptoms such as dizziness, anxiety, and sleep disturbances may occur; therefore, the dosage should be gradually reduced under a doctor's guidance. If pregnant or breastfeeding, the use of this drug should only be done after consulting a doctor as it may affect the newborn. Elderly patients should start at a lower dosage and be treated cautiously, and caution is necessary when driving or operating machinery. In case of overdose, symptoms such as central nervous system abnormalities, cardiac arrhythmias, and hypotension may occur, requiring immediate emergency treatment. This drug is not recommended for children and adolescents as its safety and efficacy have not been established.

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, hyperirritability, panic attacks, confusional state, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, syncope, serotonin syndrome, movement disorders, motor dysfunction, convulsions, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation on ECG, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, nosebleed, nausea, diarrhea, constipation, vomiting, polydipsia, 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, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorders, migraine, chest pain, frequent urination, tremor, emotional instability, hypersensitivity, visual impairment, dizziness, sleep disorders, anxiety, nausea, tremors, confusion, sweating, headache, diarrhea

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

Storage

This medication should be stored in a tightly sealed container to prevent contact with air or moisture, and it is safe to store it at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness for a long time.

Appearance and packaging

Appearance

White, rectangular 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.

Questions about this medicine

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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.