Medication info
Zepram Tablet 20mg (Escitalopram Oxalate)

Zepram Tablet 20mg (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injection
Ingredient · strength
Escitalopram Oxalate›25.54mg / 1 tablet
Manufacturer / importer
Jeil Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201708466 · Approved 2017.12.21 · Insurance code 645405140

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
Safety has not been established for doses exceeding 20mg per day. This medicine is administered once daily in the morning or evening, with or without food. 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 to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are needed for the antidepressant effect 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 the dose 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. Social anxiety disorder: The usual dose 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. To ensure a therapeutic effect, treatment is recommended to continue for 12 weeks. Long-term treatment of patients who responded was studied for 6 months. 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 treatment trial 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. 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 treatment trial 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. Patients with renal impairment: No dosage adjustment is required for patients with mild or moderate renal impairment. Caution should be exercised in patients with severe renal impairment (CLCR < 30㎖/min). Patients with hepatic impairment: An initial dose of 5mg per day is recommended for the first 2 weeks. Depending on the patient's response, the dose may be increased to 10mg per day. Discontinuation: 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 or to MAO inhibitors for the treatment of psychiatric disorders: If treatment with an MAO inhibitor for a psychiatric disorder is discontinued and treatment with this medicine is started, an interval of at least 14 days must be allowed. Conversely, if treatment with an MAO inhibitor for a psychiatric disorder is to be started, at least 14 days must have elapsed after discontinuing this medicine. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. Patients should be monitored for symptoms of serotonin syndrome at the earlier of 2 weeks after starting linezolid or intravenous methylene blue, or 24 hours after the last dose. The risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear.

Ingredients

Manufacturer
Jeil 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 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

Safety has not been established for doses exceeding 20mg per day. This medicine is administered once daily in the morning or evening, with or without food. 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 to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are needed for the antidepressant effect 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 the dose 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. Social anxiety disorder: The usual dose 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. To ensure a therapeutic effect, treatment is recommended to continue for 12 weeks. Long-term treatment of patients who responded was studied for 6 months. 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 treatment trial 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. 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 treatment trial 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. Patients with renal impairment: No dosage adjustment is required for patients with mild or moderate renal impairment. Caution should be exercised in patients with severe renal impairment (CLCR < 30㎖/min). Patients with hepatic impairment: An initial dose of 5mg per day is recommended for the first 2 weeks. Depending on the patient's response, the dose may be increased to 10mg per day. Discontinuation: 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 or to MAO inhibitors for the treatment of psychiatric disorders: If treatment with an MAO inhibitor for a psychiatric disorder is discontinued and treatment with this medicine is started, an interval of at least 14 days must be allowed. Conversely, if treatment with an MAO inhibitor for a psychiatric disorder is to be started, at least 14 days must have elapsed after discontinuing this medicine. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. Patients should be monitored for symptoms of serotonin syndrome at the earlier of 2 weeks after starting linezolid or intravenous methylene blue, or 24 hours after the last dose. The risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear.

Precautions

This medication is an antidepressant used in the treatment of psychiatric disorders such as major depression, and it works primarily by selectively inhibiting serotonin reuptake. During treatment with this medication, there may be an increased risk of suicidal thoughts or behaviors, particularly in children, adolescents, and young adults aged 18 to 24, who should be closely monitored. This medication should not be taken with certain drugs, for instance, serious side effects may occur if taken together with MAO inhibitors or pimozide. Patients with a history of glaucoma or narrow-angle glaucoma should be cautious as this medication may cause pupil dilation and increase intraocular pressure. During the first 1-2 weeks of treatment, side effects such as anxiety, insomnia, dizziness, nausea, and headaches may commonly occur, but these symptoms often alleviate over time. This medication may lower sodium levels in the blood, requiring caution in the elderly or patients at risk of hyponatremia. Additionally, this medication can affect cardiac electrical activity, so patients with QT interval prolongation or existing heart conditions should undergo an electrocardiogram before starting treatment. Suddenly stopping this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, dosage should be gradually reduced under medical supervision when discontinuing. Pregnant or breastfeeding women should consult with their healthcare provider before taking this medication, as it may affect the newborn. Caution is advised during driving or operating machinery, so patients should carefully observe their own condition after taking this medication. In case of overdose, symptoms may include central nervous system effects, gastrointestinal disturbances, and cardiac arrhythmias necessitating immediate medical attention. Finally, this medication is not recommended for use in children and adolescents due to insufficient evidence of safety and efficacy.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, nervousness, panic attack, confusion, aggression, derealization, hallucinations, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, altered perception, tremors, taste disorders, sleep disturbances, syncope, serotonin syndrome, movement disorders, motor dysfunction, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval, polymorphic ventricular tachycardia, 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, indigestion, enteritis, sensory disturbances, cough, asthma, shortness of breath, fractures, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, frequency of urination, sedation, tremor, dry mouth, heartburn, anxiety, visual hallucinations, retrograde anxiety, epileptic seizures, mania, suicidal impulses, hostility, aggressiveness, impulsivity, akathisia, hypomania, insomnia, excitement, withdrawal symptoms, dizziness, sleep disturbances, anxiety, tremors, confusion, sweating, diarrhea, emotional instability, irritability, visual impairment, QT interval prolongation, persistent sexual dysfunction

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

Storage

This medication should be stored in a light-resistant container because it is sensitive to light. Furthermore, it should be kept at room temperature, ideally between 1°C and 30°C, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

White oval 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.

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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.