Medication info
Newpram Tablets 20 mg (Escitalopram Oxalate)

Newpram Tablets 20 mg (Escitalopram Oxalate)

Prescription medicationTablet
Ingredient · strength
Escitalopram Oxalate›25.54mg / 1 tablet
Manufacturer / importer
Myeongin Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 201107539 · Notified 2011.09.30 · Insurance code 651903550

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (including 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. Administer this drug once daily, in the morning or evening, without regard to meals. Major depressive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient’s response. If increasing the dose to 20mg, increase it at intervals of at least 1 week. Antidepressant effects generally take 2-4 weeks to develop. After symptoms resolve, at least 6 months of drug treatment is needed 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. The dose may be increased to a maximum of 20mg per day according to the patient’s response. Maximum effect is achieved 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. Social anxiety disorder: The usual dose is 10mg once daily. Improvement in symptoms generally takes 2-4 weeks. Thereafter, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day according to the patient’s response. Social anxiety disorder is a chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in responding patients has been studied for 6 months; continued treatment should be considered individually to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. Generalized anxiety disorder: The initial dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient’s response 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 drug for each patient. Obsessive-compulsive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient’s response. 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 continue for a sufficient period to ensure resolution of symptoms. If this drug is administered long term, its usefulness and dose should be reassessed regularly for each patient. No dose adjustment is necessary in patients with mild or moderate renal impairment. Use with caution in patients with severe renal impairment (CLCR < 30㎖/min). An initial dose of 5mg per day for the first 2 weeks is recommended. The dose may be increased to 10mg per day according to the patient’s response. If treatment with this drug is discontinued, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms.

Ingredients

Manufacturer
Myeongin 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 medication is used for major depressive disorder and panic disorder, with or without agoraphobia. It is also effective for the treatment of social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder. This drug helps improve the symptoms of these various anxiety and mood disorders, thereby assisting patients to maintain a more stable daily life. When used safely, it plays a crucial role in the recovery of mental health. Therefore, it is used in the treatment of major depressive disorder and several anxiety-related disorders.

Dosage and Administration

Adult dosage

The safety of doses exceeding 20mg per day has not been established. Administer this drug once daily, in the morning or evening, without regard to meals. Major depressive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient’s response. If increasing the dose to 20mg, increase it at intervals of at least 1 week. Antidepressant effects generally take 2-4 weeks to develop. After symptoms resolve, at least 6 months of drug treatment is needed 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. The dose may be increased to a maximum of 20mg per day according to the patient’s response. Maximum effect is achieved 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. Social anxiety disorder: The usual dose is 10mg once daily. Improvement in symptoms generally takes 2-4 weeks. Thereafter, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day according to the patient’s response. Social anxiety disorder is a chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in responding patients has been studied for 6 months; continued treatment should be considered individually to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. Generalized anxiety disorder: The initial dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient’s response 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 drug for each patient. Obsessive-compulsive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day according to the patient’s response. 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 continue for a sufficient period to ensure resolution of symptoms. If this drug is administered long term, its usefulness and dose should be reassessed regularly for each patient. No dose adjustment is necessary in patients with mild or moderate renal impairment. Use with caution in patients with severe renal impairment (CLCR < 30㎖/min). An initial dose of 5mg per day for the first 2 weeks is recommended. The dose may be increased to 10mg per day according to the patient’s response. If treatment with this drug is discontinued, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms.

Precautions

This medication is an antidepressant used to treat psychiatric disorders such as major depression. It can increase the risk of suicidal thoughts or suicidal behavior in children, adolescents, and young adults aged 18 to 24, so physicians should carefully assess the patient's condition when prescribing this medication. If depressive symptoms worsen or if unusual behavioral changes such as suicidal thoughts, aggression, or anger arise while taking this medication, the patient should consult healthcare professionals immediately. Particularly, the safety and efficacy of this medication have not been established for children and adolescents, and its use is not recommended. This medication can be risky when combined with certain drugs, so patients taking MAO inhibitors, pimozide, or medications that prolong the QT interval must inform their healthcare provider and should avoid combining these medications. Patients with closed-angle glaucoma or a history of glaucoma need to be cautious as this medication can dilate pupils and increase intraocular pressure. Various adverse reactions can occur with this medication; during the initial 1-2 weeks of treatment, symptoms such as insomnia, dizziness, nausea, headache, and fatigue may commonly arise but usually lessen over time. Additionally, this medication can lower sodium levels in the blood and increase the risk of bleeding, so patients with a tendency to bleed or those taking drugs that affect blood coagulation should be cautious. When discontinuing this medication, the dosage should not be stopped abruptly but should be gradually reduced according to the physician's instructions; otherwise, withdrawal symptoms like dizziness, anxiety, and sleep disturbances may occur. Women who are pregnant or breastfeeding should consult with their physician about the use of this medication, particularly in late pregnancy due to potential effects on the newborn. Elderly patients should start with a lower initial dose and adjust it carefully, especially if they have heart disease. This medication does not substantially affect driving or operating machinery; however, drowsiness or dizziness may occur in some individuals, so caution is advised. In case of overdose, central nervous system symptoms, gastrointestinal disturbances, and cardiac arrhythmias may arise, necessitating immediate emergency care, as there is no specific antidote. Finally, this medication should be kept out of the reach of children and should not be transferred to other containers for safety.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, anxiety, agitation, abnormal dreams, decreased libido, sexual dysfunction, bruxism, restlessness, irritability, panic attacks, confusion, aggression, depersonalization, hallucination, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, paresthesia, tremor, taste disorder, sleep disorder, syncope, serotonin syndrome, motor abnormalities, movement disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation in ECG, polymorphic ventricular tachycardia, ventricular arrhythmias, 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, ejaculatory dysfunction, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory abnormalities, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorders, migraine, chest pain, frequent urination, sedation, tremor, dry mouth, heartburn, anxiety, visual hallucination, dry mouth syndrome, withdrawal symptoms, dizziness, sleep disorder, anxiety, tremor, confusion, sweating, headache, diarrhea, palpitations

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. Proper storage will help preserve the effectiveness of the drug.

Appearance and packaging

Appearance

White oval film-coated tablet

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.