Medication info
Sandoz Escitalopram Tablets 15 mg

Sandoz Escitalopram Tablets 15 mg

Prescription medicationTablet
Ingredient · strength
Escitalopram Oxalate›19.16mg / 1 tablet
Manufacturer / importer
Samil Pharm. Co., Ltd.
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201401785 · Approved 2014.04.14 · Insurance code 643904050

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (panic disorder, social anxiety disorder, etc.), 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. 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 of this medication is to be increased to 20mg, it should be increased at intervals of at least 1 week. In general, 2-4 weeks are required for antidepressant effects to develop. Even after symptoms have resolved, at least 6 months of drug therapy is required to ensure the treatment 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 it 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 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 required 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 it is recommended that treatment continue for 12 weeks to ensure the treatment effect. Long-term treatment in patients who respond has been 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 reevaluated. 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. Drug treatment has not been compared with cognitive behavioral therapy. Drug treatment is one part of an overall treatment strategy. (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, with 20mg per day administered for at least 6 months. The physician should periodically reevaluate 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 administration study was conducted in patients who responded to 16 weeks of open-label treatment, with 10mg or 20mg per day administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so treatment should be continued for a sufficient period to ensure symptom recovery. If this medication is administered long term, its usefulness and dosage should be periodically reevaluated for each patient. 2) Patients with renal impairment No dose adjustment is required 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 It is recommended to administer an initial dose of 5mg per day for the first 2 weeks. The dose may be increased to 10mg per day, depending on the patient's response. 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 used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medication, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, 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 should not start 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, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. If there is no alternative to linezolid or intravenous methylene blue 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 comes first. Treatment with this medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this medication at a dose of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Importer
Samil Pharm. Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (panic disorder, social anxiety disorder, etc.), 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 mental health issues such as major depressive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder.

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. 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 of this medication is to be increased to 20mg, it should be increased at intervals of at least 1 week. In general, 2-4 weeks are required for antidepressant effects to develop. Even after symptoms have resolved, at least 6 months of drug therapy is required to ensure the treatment 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 it 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 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 required 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 it is recommended that treatment continue for 12 weeks to ensure the treatment effect. Long-term treatment in patients who respond has been 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 reevaluated. 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. Drug treatment has not been compared with cognitive behavioral therapy. Drug treatment is one part of an overall treatment strategy. (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, with 20mg per day administered for at least 6 months. The physician should periodically reevaluate 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 administration study was conducted in patients who responded to 16 weeks of open-label treatment, with 10mg or 20mg per day administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so treatment should be continued for a sufficient period to ensure symptom recovery. If this medication is administered long term, its usefulness and dosage should be periodically reevaluated for each patient. 2) Patients with renal impairment No dose adjustment is required 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 It is recommended to administer an initial dose of 5mg per day for the first 2 weeks. The dose may be increased to 10mg per day, depending on the patient's response. 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 used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medication, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, 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 should not start 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, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. If there is no alternative to linezolid or intravenous methylene blue 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 comes first. Treatment with this medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this medication at a dose of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Precautions

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, so careful judgment is required when prescribing to patients of this age group. This medication should not be used in patients with hypersensitivity to the active ingredient or other components, patients currently taking MAO inhibitors, patients taking Pimodidine, or patients with a history of QT interval prolongation or those taking medications that cause QT interval prolongation. Patients with closed-angle glaucoma or a history of glaucoma should be cautious, as this medication may cause pupil dilation and increased intraocular pressure. During the first 1-2 weeks of treatment, common adverse reactions include anxiety, insomnia, dizziness, nausea, and fatigue, which often improve over time. This medication may increase the risk of seizures in patients with epilepsy, so careful monitoring is necessary for epilepsy patients. During treatment, if signs of worsening depression, suicidal thoughts, aggression, anxiety, or other abnormal behavior changes occur, the patient and caregiver should carefully observe the condition and consult with a physician immediately if any unusual symptoms arise. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it should not be stopped suddenly and should be gradually tapered under medical supervision. Patients with cardiac disease or concerns about QT interval prolongation should undergo an electrocardiogram before taking this medication and should regularly monitor their cardiac condition during treatment. This medication should be used with caution in pregnant women, particularly in late pregnancy and nursing mothers, as it may affect the baby through breast milk; discontinuation of breastfeeding is recommended during treatment. This medication may interact with various other medications, so patients taking other medications should inform their doctor or pharmacist, especially avoiding concurrent use with MAO inhibitors, Pimodidine, anticoagulants, and certain antipsychotics. Caution is advised when driving or operating machinery as it may affect mental and motor skills. This medication requires dose adjustment when administering to children and the elderly, with elderly patients advised to start at a lower initial dose and increase carefully.

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 attack, confusion, aggression, depersonalization, hallucination, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, fainting, serotonin syndrome, dyskinesia, movement disorders, seizures, psychomotor agitation, inability to sit still, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation, 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, itching, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculatory dysfunction, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, sexual dysfunction, palpitations, paralysis, extrapyramidal symptoms, migraine, asthma, dyspnea, fracture, hypertension, insomnia, aggressive reactions, anorexia, hallucinations, sedation, polyuria, tremor, polydipsia, emotional instability, hypersensitivity, visual impairment, dizziness, sleep disorders, anxiety, tremors, confusion, diarrhea, palpitations, sensory disturbances, withdrawal symptoms, hypokalemia, hypomagnesemia

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

Storage

This medication should be stored in a tightly closed container that blocks light and kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness and prevents degradation.

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.

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.