Medication info
New Pram Tablet 5mg (Escitalopram Oxalate)

New Pram Tablet 5mg (Escitalopram Oxalate)

Prescription medicationTablet
Ingredient · strength
Escitalopram Oxalate›6.39mg / 1 tablet
Manufacturer / importer
Myeongin Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 201004680 · Notified 2010.07.26 · Insurance code 651903320

Summary

Main use
Treatment of depressive and anxiety disorders (e.g., panic disorder and social anxiety disorder) and obsessive-compulsive disorder
Who uses it
Adults
Adult dosage
The safety of doses exceeding 20mg per day has not been established. This medicine is administered once daily in the morning or evening, regardless of meals. 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 increasing the dose of this medicine 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 become apparent. Even after symptoms have resolved, drug treatment for at least 6 months is required to ensure a therapeutic effect. 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. 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 chronic condition, and it is recommended that treatment be continued for 12 weeks to ensure a therapeutic effect. Long-term treatment in patients who respond 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. 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 treatment 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. 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 treatment 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; treatment should be continued for a sufficient period to ensure recovery from symptoms. When this medicine is used long term, its usefulness and dosage should be reassessed regularly for each patient. Patients with renal impairment: No dose adjustment is needed in patients with mild or moderate renal impairment. Caution is required in patients with severe renal impairment (CLCR < 30mL/min). 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. 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. 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 must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue: Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require other interventions, including hospitalization, or treatment for a more urgent psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available 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 medicine 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered 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. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Myeongin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of depressive and 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 drug is used for the treatment of major depressive disorder, panic disorder (including cases with or without agoraphobia), social anxiety disorder (social phobia), 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 medicine is administered once daily in the morning or evening, regardless of meals. 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 increasing the dose of this medicine 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 become apparent. Even after symptoms have resolved, drug treatment for at least 6 months is required to ensure a therapeutic effect. 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. 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 chronic condition, and it is recommended that treatment be continued for 12 weeks to ensure a therapeutic effect. Long-term treatment in patients who respond 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. 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 treatment 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. 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 treatment 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; treatment should be continued for a sufficient period to ensure recovery from symptoms. When this medicine is used long term, its usefulness and dosage should be reassessed regularly for each patient. Patients with renal impairment: No dose adjustment is needed in patients with mild or moderate renal impairment. Caution is required in patients with severe renal impairment (CLCR < 30mL/min). 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. 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. 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 must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue: Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require other interventions, including hospitalization, or treatment for a more urgent psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available 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 medicine 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered 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. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Precautions

This drug is an antidepressant used for the treatment of psychiatric disorders such as major depression. During the course of this medication, there may be an increased risk of suicidal thoughts or behavior in children, adolescents, and young adults, so they should be closely monitored. This drug should not be administered to patients with a known allergy to escitalopram or those taking MAO inhibitors, pimozide, or drugs that prolong the QT interval. Patients with closed-angle glaucoma or a history of glaucoma should exercise caution, as this drug may dilate the pupil and increase intraocular pressure. Common side effects such as anxiety, insomnia, dizziness, and nausea may occur during the first 1-2 weeks of use, but symptoms may diminish over time. This drug can cause a serious side effect known as serotonin syndrome; therefore, caution is especially needed when used in combination with other serotonergic drugs. When discontinuing this medication, do not stop suddenly and gradually reduce the dose as directed by your physician, as a sudden discontinuation may lead to withdrawal symptoms such as dizziness, anxiety, or sleep disturbances. This drug may cause QT interval prolongation, so patients with heart disease or electrolyte imbalances should have cardiac examinations and be cautious. Pregnant or nursing women should consult their doctor before taking this medication, as it may affect the newborn. Elderly patients should start with a lower initial dose and adjust carefully. Caution may be necessary while driving or operating machinery, so patients should assess their condition after taking the drug. The safety and efficacy of this drug have not been established in children and adolescents, so its use is not recommended. There may be an increased tendency to bleed while taking this drug; therefore, caution is advised when taking anticoagulants or medications that increase bleeding risk. In case of overdose, central nervous system symptoms, gastrointestinal symptoms, and cardiac arrhythmias may occur, requiring immediate medical attention. This medication should be kept out of reach of children and should not be transferred to other containers.

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, hallucinations, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, syncope, serotonin syndrome, dyskinesia, movement disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmias, orthostatic hypotension, sinusitis, yawning, epistaxis, nausea, diarrhea, constipation, vomiting, polydipsia, gastrointestinal bleeding, hepatitis, abnormal liver function test, increased sweating, urticaria, hair loss, rash, itching, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculation problems, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fractures, palpitations, hypertension, paralysis, extrapyramidal disorders, migraine, chest pain, frequent urination, sedation, tremor, dry mouth, heartburn, anxiety, visual hallucinations, retrograde anxiety, epileptic seizures, mania, changes in blood sugar control, suicidal urges, abnormal behavioral changes, hostility, aggressiveness, impulsivity, akathisia, hypomania, increased anxiety symptoms, withdrawal symptoms, dizziness, sleep disorders, anxiety, tremors, confusion, sweating, diarrhea, emotional instability, irritability, visual impairment, QT interval prolongation, sexual dysfunction, persistent sexual dysfunction, hypokalemia, hypomagnesemia, hypotension, arrhythmia, hyponatremia

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

Storage

This medication may be sensitive to air or moisture and should be stored in a tightly closed container. Additionally, it is best to store it at room temperature between 1 and 30 degrees Celsius. This will help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 200 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.