Serocaba Tablet (Escitalopram Oxalate)

Adult dosage

Safety has not been established for doses exceeding 20mg per day. This drug is administered once daily in the morning or evening, with or without food. 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 drug to 20mg, the dose should be increased 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 necessary 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. Maximum effects appear 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. (3) Social anxiety disorder: The usual dose is 10mg once daily. Generally, 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment of responders 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 periodically. 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 treatment trial was conducted in patients who responded to 12 weeks of open-label treatment, administering 20mg per day for at least 6 months. The physician should periodically reassess the usefulness of long-term treatment with this drug 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 treatment trial was conducted in patients who responded to 16 weeks of open-label treatment, administering 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition; treatment should be continued for a sufficient period to ensure recovery of symptoms. When this drug is administered long term, its usefulness and dose should be reassessed periodically for each patient. 2) Patients with renal impairment No dose adjustment is necessary in 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 When discontinuing this drug, 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 drug, an interval of at least 14 days should be observed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days should elapse after discontinuing this drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug 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 occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this drug 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.

This drug may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders; therefore, caution is advised when administering to patients in this age group. This drug should not be taken with certain medications, particularly MAO inhibitors or pimavanserin, and should not be administered to patients currently taking medications that prolong the QT interval. Patients with a history of glaucoma or angle-closure glaucoma may experience increased intraocular pressure due to the drug’s mydriatic effects, requiring careful monitoring. Various adverse reactions, including anxiety, insomnia, tremors, and nausea, may occur during the first 1-2 weeks of administration, but these symptoms tend to decrease over time. During the use of this drug, there may be worsening of depressive symptoms, suicidal thoughts, and aggression, so patients and families should monitor closely. Abrupt cessation of this medication may provoke withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; thus, the dosage should be gradually reduced according to a doctor's instructions. This drug may prolong the QT interval related to heart rhythm; therefore, patients with heart disease or those taking related medications may require an electrocardiogram prior to administration. Pregnant or breastfeeding women should consult a doctor before taking this medication as it may affect the newborn; discontinuing breastfeeding is recommended while taking this drug. Elderly patients should start with a lower initial dose and cautiously increase it, while diabetic patients should be aware of possible changes in blood sugar control. This drug does not have a significant impact on driving or operating machinery, but individual effects on mental function may vary, warranting caution. In case of overdose, central nervous system, gastrointestinal, and cardiovascular symptoms may arise, necessitating immediate medical attention. This medication should be kept out of reach of children, and transferring it to another container may compromise its quality, so this should be avoided.

Thrombocytopenia, anaphylactic reaction, inappropriate secretion of antidiuretic hormone, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, loss of appetite, 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, movement disorders, dyskinesia, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation on ECG, polymorphic ventricular tachycardia, ventricular arrhythmia, 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, ejaculation disorder, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbance, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, tremor, dry mouth, frequent urination, sedation, heartburn, anxiety, visual hallucinations, xerostomia, withdrawal symptoms, dizziness, sleep disorders, anxiety, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual impairment, hypokalemia, hypomagnesemia, persistent sexual dysfunction

This medication can be sensitive to air and moisture, therefore, it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication’s efficacy for a longer period.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle